The following data is part of a premarket notification filed by Medical Products Development, Inc. with the FDA for Replacable Battery Hi-temp Cautery.
Device ID | K810014 |
510k Number | K810014 |
Device Name: | REPLACABLE BATTERY HI-TEMP CAUTERY |
Classification | Apparatus, Electrosurgical |
Applicant | MEDICAL PRODUCTS DEVELOPMENT, 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 | 1981-01-05 |
Decision Date | 1981-02-12 |