The following data is part of a premarket notification filed by Key Surgical, Inc. with the FDA for Key Comfort Grips.
| Device ID | K910328 |
| 510k Number | K910328 |
| Device Name: | KEY COMFORT GRIPS |
| Classification | Tray, Surgical, Instrument |
| 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 | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-25 |
| Decision Date | 1991-03-06 |