The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Electrosurgical Tip Cleaner & Holder.
Device ID | K803055 |
510k Number | K803055 |
Device Name: | ELECTROSURGICAL TIP CLEANER & HOLDER |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | DEVON INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-02 |
Decision Date | 1981-02-12 |