The following data is part of a premarket notification filed by Microvasive with the FDA for Thermal Coagulator.
Device ID | K870705 |
510k Number | K870705 |
Device Name: | THERMAL COAGULATOR |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
Contact | Samuel D Wade |
Correspondent | Samuel D Wade MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-20 |
Decision Date | 1987-04-17 |