The following data is part of a premarket notification filed by International Medsurg Connection with the FDA for Surgical Drapes.
| Device ID | K971159 |
| 510k Number | K971159 |
| Device Name: | SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | INTERNATIONAL MEDSURG CONNECTION 1000 E. WOODFIELD RD. SUIT3 117 Schaumberg, IL 60173 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons INTERNATIONAL MEDSURG CONNECTION 1000 E. WOODFIELD RD. SUIT3 117 Schaumberg, IL 60173 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-06-24 |
| Summary: | summary |