The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Meniscal Suture Gun.
| Device ID | K832978 |
| 510k Number | K832978 |
| Device Name: | MENISCAL SUTURE GUN |
| Classification | Guide, Needle, Surgical |
| Applicant | INSTRUMENT MAKAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-02 |
| Decision Date | 1983-12-12 |