The following data is part of a premarket notification filed by Repack Surgical Enterprises, Inc. with the FDA for Repak Surgical Packs.
| Device ID | K903908 |
| 510k Number | K903908 |
| Device Name: | REPAK SURGICAL PACKS |
| Classification | Drape, Surgical |
| Applicant | REPACK SURGICAL ENTERPRISES, INC. ONE KNOLLCREST DR. P.O. BOX 37890 Cincinnati, OH 45222 -1805 |
| Contact | Barbara Stanewick |
| Correspondent | Barbara Stanewick REPACK SURGICAL ENTERPRISES, INC. ONE KNOLLCREST DR. P.O. BOX 37890 Cincinnati, OH 45222 -1805 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-23 |
| Decision Date | 1990-10-26 |