The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Meniscus Mender Ii Loop.
| Device ID | K885311 |
| 510k Number | K885311 |
| Device Name: | MENISCUS MENDER II LOOP |
| Classification | Passer |
| Applicant | INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Contact | Rick L Masters |
| Correspondent | Rick L Masters INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Product Code | HWQ |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-29 |
| Decision Date | 1989-02-09 |