The following data is part of a premarket notification filed by Endo Optics, Inc. with the FDA for Endo Optiks Value Pack.
| Device ID | K923600 |
| 510k Number | K923600 |
| Device Name: | ENDO OPTIKS VALUE PACK |
| Classification | General Surgery Tray |
| Applicant | ENDO OPTICS, INC. C/O KNOPF ASSOCIATES, INC. 28 MARIGOLD LANE Marlboro, NJ 07746 |
| Contact | Martin S Knopf |
| Correspondent | Martin S Knopf ENDO OPTICS, INC. C/O KNOPF ASSOCIATES, INC. 28 MARIGOLD LANE Marlboro, NJ 07746 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-20 |
| Decision Date | 1993-03-23 |