The following data is part of a premarket notification filed by Renew Medical, Inc. with the FDA for Renew Insert.
| Device ID | K122003 |
| 510k Number | K122003 |
| Device Name: | RENEW INSERT |
| Classification | Rectal Insert |
| Applicant | RENEW MEDICAL, INC. 532 EMERSON STREET Palo Alto, CA 94301 |
| Contact | Victoria Mackinnon |
| Correspondent | Victoria Mackinnon RENEW MEDICAL, INC. 532 EMERSON STREET Palo Alto, CA 94301 |
| Product Code | PBP |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-09 |
| Decision Date | 2012-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10867476000043 | K122003 | 000 |
| 10867476000036 | K122003 | 000 |
| 10867476000029 | K122003 | 000 |
| 00861680000472 | K122003 | 000 |
| 00861680000465 | K122003 | 000 |
| 00861680000458 | K122003 | 000 |
| 00861680000427 | K122003 | 000 |
| 00861680000410 | K122003 | 000 |
| 00861680000403 | K122003 | 000 |