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1	FDA > CDRH > 510(k) Premarket Notification Database Search www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm - Get Site Info
2	US FDA/CDRH: Information on Releasable 510(k)s Information on 510(k) premarket notifications releasable under the Freedom of Information Act. www.fda.gov/cdrh/510khome.html - Get Site Info
3	Premarket Notification (510k) Premarket Notification (510(k): discussion of substantial evidence, who is required to submit, when required and not required, third party review program, with references www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/H owtoMarketYourDevice/PremarketSubmissions/PremarketNotif ication510k/ - Get Site Info
4	US FDA/CDRH: Device Advice - How to Prepare a Traditional 510(k) Device Advice - How to Prepare a Traditional 510(k) www.fda.gov/cdrh/devadvice/3143.html - Get Site Info
5	US FDA/CDRH: Deciding When to Submit a 510(k) for a Change to an Existing Device The purpose of this guidance is to provide direction to manufacturers on deciding when to submit a 510(k) for a change to an existing device. www.fda.gov/cdrh/ode/510kmod.html - Get Site Info
6	Content Of A 510(k) www.fda.gov/cdrh/devadvice/314312.html - Get Site Info
7	US FDA/CDRH: Device Advice - Premarket Notification 510(k) Premarket Notification (510(k): discussion of substantial evidence, who is required to submit, when required and not required, third party review program, with references. www.fda.gov/cdrh/devadvice/314.html - Get Site Info
8	FDA > CDRH > CFR Title 21 Database Search www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSear ch.cfm - Get Site Info
9	510(k) Submission Process www.fda.gov/cdrh/devadvice/31435.html - Get Site Info
10	MDUFMA User Fee Cover Sheet www.fda.gov/oc/mdufma/coversheet.html - Get Site Info

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U.S. FDA/CDRH: Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff Guidance - Format for Traditional and Abbreviated 510(k)s www.fda.gov/cdrh/ode/guidance/1567.htm l - Get Site Info