The following data is part of a premarket notification filed by Key Medical, Inc. with the FDA for Micro Cautery.
Device ID | K810909 |
510k Number | K810909 |
Device Name: | MICRO CAUTERY |
Classification | Apparatus, Electrosurgical |
Applicant | KEY MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HAM |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-03 |
Decision Date | 1981-04-17 |