The following data is part of a premarket notification filed by Inamed Development Co. with the FDA for Inamed Pro-tec Silicone Surgical Gloves.
| Device ID | K894073 |
| 510k Number | K894073 |
| Device Name: | INAMED PRO-TEC SILICONE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | INAMED DEVELOPMENT CO. 1035 A. CINDY LN. Carpinteria, CA 93013 |
| Contact | Ellen Duke |
| Correspondent | Ellen Duke INAMED DEVELOPMENT CO. 1035 A. CINDY LN. Carpinteria, CA 93013 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-08 |
| Decision Date | 1989-09-18 |