The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Instrument Makar Gravity Assist System.
| Device ID | K905365 |
| 510k Number | K905365 |
| Device Name: | INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Contact | Keith M Mcgrath |
| Correspondent | Keith M Mcgrath INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-21 |
| Decision Date | 1991-02-06 |