FROG
FDA 510(k) clearance K072831 · decided 2008-12-12
Clearance details
- K-number
- K072831
- Device name
- FROG
- Applicant
- Newby-Coombs, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-10-03
- Decision date
- 2008-12-12
- Days to decision
- 436 days
- Clearance type
- Traditional
- Product code
- FPD
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Branchville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.