The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Pediatric Laparotomy Sheet #7938/ #7938ns.
| Device ID | K946024 |
| 510k Number | K946024 |
| Device Name: | 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS |
| Classification | Drape, Surgical |
| Applicant | 3M HEALTH CARE 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 -1000 |
| Contact | Marvin L Hart |
| Correspondent | Marvin L Hart 3M HEALTH CARE 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 -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 | 1995-02-08 |