The following data is part of a premarket notification filed by Her-mar, Inc. with the FDA for Surgical Instrument, Disposable.
| Device ID | K940684 |
| 510k Number | K940684 |
| Device Name: | SURGICAL INSTRUMENT, DISPOSABLE |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | HER-MAR, INC. P.O. BOX 402916 Miami Beach, FL 33140 |
| Contact | Ronald Mayer |
| Correspondent | Ronald Mayer HER-MAR, INC. P.O. BOX 402916 Miami Beach, FL 33140 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-10 |
| Decision Date | 1994-03-14 |