The following data is part of a premarket notification filed by Brant-wald Surgicals, Inc. with the FDA for Sterile Disposable Pn Drape System.
| Device ID | K850912 |
| 510k Number | K850912 |
| Device Name: | STERILE DISPOSABLE PN DRAPE SYSTEM |
| Classification | Drape, Surgical |
| Applicant | BRANT-WALD SURGICALS, INC. P.O. BOX 4962 Oak Ridge, TN 37831 |
| Contact | Rayburn C Waldrop |
| Correspondent | Rayburn C Waldrop BRANT-WALD SURGICALS, INC. P.O. BOX 4962 Oak Ridge, TN 37831 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-05 |
| Decision Date | 1985-05-03 |