The following data is part of a premarket notification filed by American Safety Equipment Corp. with the FDA for Surgical Micro Drill.
Device ID | K760956 |
510k Number | K760956 |
Device Name: | SURGICAL MICRO DRILL |
Classification | Drill, Dental, Intraoral |
Applicant | AMERICAN SAFETY EQUIPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DZA |
CFR Regulation Number | 872.4130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-11-01 |
Decision Date | 1976-11-19 |