RENEW INSERT— 510(k) K122003
Substantially EquivalentRenew Medical, Inc.
FDA 510(k) clearance K122003 for RENEW INSERT, Substantially Equivalent on 2012-10-26. Applicant: Renew Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Renew Medical, Inc.
- Product code
- Code PBP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
Recent devices under product code PBP
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