The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Bow & Arrow Drill Guide.
| Device ID | K882407 |
| 510k Number | K882407 |
| Device Name: | BOW & ARROW DRILL GUIDE |
| Classification | Guide, Drill, Ligament |
| Applicant | INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Contact | Dean Z Look |
| Correspondent | Dean Z Look INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Product Code | LXI |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-10 |
| Decision Date | 1988-09-06 |