The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Bovie 400-ct Electrosurgical Generator (unit).
Device ID | K872705 |
510k Number | K872705 |
Device Name: | BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester, NY 14692 |
Contact | Scoville, Jr. |
Correspondent | Scoville, Jr. CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester, NY 14692 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-07 |
Decision Date | 1987-09-01 |