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 |