The following data is part of a premarket notification filed by Medical Design Llc. with the FDA for Hand Drill, Model 11-9901-7.
| Device ID | K022712 |
| 510k Number | K022712 |
| Device Name: | HAND DRILL, MODEL 11-9901-7 |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | MEDICAL DESIGN LLC. 213 SUNSET DR. Brandon, SD 57005 |
| Contact | Paul John Axt |
| Correspondent | Paul John Axt MEDICAL DESIGN LLC. 213 SUNSET DR. Brandon, SD 57005 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-14 |
| Decision Date | 2002-11-12 |
| Summary: | summary |