The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Dry Gel.
Device ID | K833441 |
510k Number | K833441 |
Device Name: | DRY GEL |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-05 |
Decision Date | 1983-11-29 |