The following data is part of a premarket notification filed by 3m Company with the FDA for Steri-drape Surgical Drapes.
| Device ID | K031287 |
| 510k Number | K031287 |
| Device Name: | STERI-DRAPE SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55133 -3275 |
| Contact | Scott S Sardeson |
| Correspondent | Scott S Sardeson 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55133 -3275 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-23 |
| Decision Date | 2003-09-10 |
| Summary: | summary |