The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Prevention Fabric Surgical Gown #78xx.
| Device ID | K930681 |
| 510k Number | K930681 |
| Device Name: | 3M PREVENTION FABRIC SURGICAL GOWN #78XX |
| Classification | Gown, Surgical |
| Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Contact | Marvin L Hart |
| Correspondent | Marvin L Hart 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-10 |
| Decision Date | 1994-02-10 |