The following data is part of a premarket notification filed by Sutter Biomedical, Inc. with the FDA for Silicone Implants.
| Device ID | K812691 |
| 510k Number | K812691 |
| Device Name: | SILICONE IMPLANTS |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | SUTTER BIOMEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-22 |
| Decision Date | 1981-11-16 |