The following data is part of a premarket notification filed by Key Surgical, Inc. with the FDA for Silicone Instrument Shods.
| Device ID | K895591 |
| 510k Number | K895591 |
| Device Name: | SILICONE INSTRUMENT SHODS |
| Classification | Clamp, Surgical, General & Plastic Surgery |
| Applicant | KEY SURGICAL, INC. 7101 YORK AVENUE SOUTH Minneapolis, MN 55435 -4450 |
| Contact | Kay Nordbye |
| Correspondent | Kay Nordbye KEY SURGICAL, INC. 7101 YORK AVENUE SOUTH Minneapolis, MN 55435 -4450 |
| Product Code | GDJ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-15 |
| Decision Date | 1989-10-20 |