The following data is part of a premarket notification filed by Starion Instruments with the FDA for Thermal Cautery Forceps.
Device ID | K001262 |
510k Number | K001262 |
Device Name: | THERMAL CAUTERY FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | STARION INSTRUMENTS 20665 4TH ST. Saratoga, CA 95070 |
Contact | Brian Grigsby |
Correspondent | Brian Grigsby STARION INSTRUMENTS 20665 4TH ST. Saratoga, CA 95070 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-19 |
Decision Date | 2000-06-14 |