The following data is part of a premarket notification filed by Jeneric Ind. with the FDA for Surgical Vitex.
| Device ID | K862926 |
| 510k Number | K862926 |
| Device Name: | SURGICAL VITEX |
| Classification | Implant, Subperiosteal |
| Applicant | JENERIC IND. 125 NORTH PLAINS INDUST. RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Martin L Schulman |
| Correspondent | Martin L Schulman JENERIC IND. 125 NORTH PLAINS INDUST. RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | ELE |
| CFR Regulation Number | 872.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-01 |
| Decision Date | 1986-08-29 |