The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m X-large Sheet #7979/ #7979ns.
| Device ID | K946025 |
| 510k Number | K946025 |
| Device Name: | 3M X-LARGE SHEET #7979/ #7979NS |
| Classification | Drape, Surgical |
| Applicant | 3M HEALTH CARE P.O. BOX 33275 3M CENTER, 275-3E-08 St. Paul, MN 55144 -1000 |
| Contact | Marvin L Hart |
| Correspondent | Marvin L Hart 3M HEALTH CARE P.O. BOX 33275 3M CENTER, 275-3E-08 St. Paul, MN 55144 -1000 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-09 |
| Decision Date | 1995-02-02 |