The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Surgical Drapes.
| Device ID | K943122 |
| 510k Number | K943122 |
| Device Name: | SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | M.l. Friedman, Ph.d. |
| Correspondent | M.l. Friedman, Ph.d. MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1994-09-07 |