The following data is part of a premarket notification filed by Apex Ent., Inc. with the FDA for Apex Disposable Instruments.
| Device ID | K941907 |
| 510k Number | K941907 |
| Device Name: | APEX DISPOSABLE INSTRUMENTS |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | APEX ENT., INC. P.O. BOX 11286 Fairfield, NJ 07004 |
| Contact | Aftab Ahmed |
| Correspondent | Aftab Ahmed APEX ENT., INC. P.O. BOX 11286 Fairfield, NJ 07004 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-19 |
| Decision Date | 1994-08-26 |