The following data is part of a premarket notification filed by Solidence Surgical Corporation with the FDA for Solidence Multipockets.
| Device ID | K191131 |
| 510k Number | K191131 |
| Device Name: | Solidence Multipockets |
| Classification | Wrap, Sterilization |
| Applicant | Solidence Surgical Corporation 1104 San Fernando Road San Fernando, CA 91340 |
| Contact | Morris Azad |
| Correspondent | Morris Azad Solidence Surgical Corporation 2251 San Diego Avenue, Suite B-257 San Fernando, CA 91340 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2022-08-03 |