The following data is part of a premarket notification filed by Repack Surgical Enterprises, Inc. with the FDA for Repak Surgical Pack (gown,towel,major,drape,basic).
| Device ID | K880942 |
| 510k Number | K880942 |
| Device Name: | REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) |
| Classification | General Surgery Tray |
| Applicant | REPACK SURGICAL ENTERPRISES, INC. ONE KNOLLCREST DR. P.O. BOX 37890 Cincinnati, OH 45222 -1805 |
| Contact | Rob Lowenstein |
| Correspondent | Rob Lowenstein REPACK SURGICAL ENTERPRISES, INC. ONE KNOLLCREST DR. P.O. BOX 37890 Cincinnati, OH 45222 -1805 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-07 |
| Decision Date | 1988-03-21 |