The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Clev-dent Colhs Electrosurg, Molel Tr-5.
Device ID | K770969 |
510k Number | K770969 |
Device Name: | CLEV-DENT COLHS ELECTROSURG, MOLEL TR-5 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CAVITRON CORP. 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 | 1977-05-31 |
Decision Date | 1977-06-24 |