The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Repak Surgical Packs - Gown/towel/major/drape/bas..
| Device ID | K882684 |
| 510k Number | K882684 |
| Device Name: | REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS. |
| Classification | General Surgery Tray |
| Applicant | STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Contact | Rob Lowenstein |
| Correspondent | Rob Lowenstein STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-30 |
| Decision Date | 1988-08-03 |