The following data is part of a premarket notification filed by 3m Company Corp with the FDA for 3m Basic Disposable Surgical Gown, 3m Hp Disposable Surgical Gown, 3m Reinforced Disposable Surgical Gown, 3m Disposable.
| Device ID | K101468 |
| 510k Number | K101468 |
| Device Name: | 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE |
| Classification | Gown, Surgical |
| Applicant | 3M COMPANY CORP 3M CENTER, BLDG 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Linda Johnson |
| Correspondent | Linda Johnson 3M COMPANY CORP 3M CENTER, BLDG 275-5W-06 St. Paul, MN 55144 -1000 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-27 |
| Decision Date | 2011-04-14 |
| Summary: | summary |