The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Opsite Speciality Drapes.
| Device ID | K872757 |
| 510k Number | K872757 |
| Device Name: | OPSITE SPECIALITY DRAPES |
| Classification | Drape, Surgical |
| Applicant | SMITH & NEPHEW, INC. 1875 HARSH AVE.S.E. P.O.BOX 550 Massillon, OH 44648 -0550 |
| Contact | Gregory, Jr |
| Correspondent | Gregory, Jr SMITH & NEPHEW, INC. 1875 HARSH AVE.S.E. P.O.BOX 550 Massillon, OH 44648 -0550 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-13 |
| Decision Date | 1987-07-28 |