The following data is part of a premarket notification filed by Depuy-raynham with the FDA for Repel(tm) Lite Cut Resistant Glove Liners.
| Device ID | K914077 |
| 510k Number | K914077 |
| Device Name: | REPEL(TM) LITE CUT RESISTANT GLOVE LINERS |
| Classification | Accessory, Surgical Apparel |
| Applicant | DEPUY-RAYNHAM P.O. BOX 988 Warsaw, IN 46580 |
| Contact | David A Kotkovetz |
| Correspondent | David A Kotkovetz DEPUY-RAYNHAM P.O. BOX 988 Warsaw, IN 46580 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-11 |
| Decision Date | 1991-12-02 |