The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Steri-drape Fabric Surgical Drapes.
| Device ID | K140330 |
| 510k Number | K140330 |
| Device Name: | 3M STERI-DRAPE FABRIC SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | 3M HEALTH CARE BUILDING 275-5W-06 St Paul, MN 55144 -1000 |
| Contact | Mark Burville |
| Correspondent | Mark Burville 3M HEALTH CARE BUILDING 275-5W-06 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 | 2014-02-10 |
| Decision Date | 2014-08-18 |
| Summary: | summary |