The following data is part of a premarket notification filed by Webster Enterprises, Inc. with the FDA for Surgical Drape Pack.
| Device ID | K864899 |
| 510k Number | K864899 |
| Device Name: | SURGICAL DRAPE PACK |
| Classification | Drape, Surgical |
| Applicant | WEBSTER ENTERPRISES, INC. P.O. BOX 220 Webster, NC 28788 |
| Contact | Gene Robinson |
| Correspondent | Gene Robinson WEBSTER ENTERPRISES, INC. P.O. BOX 220 Webster, NC 28788 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1987-01-20 |