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 |