The following data is part of a premarket notification filed by Starion Instruments with the FDA for Thermal Cautery Device, Forceps.
Device ID | K990728 |
510k Number | K990728 |
Device Name: | THERMAL CAUTERY DEVICE, FORCEPS |
Classification | Unit, Cautery, Thermal, Battery-powered |
Applicant | STARION INSTRUMENTS 22900 CONGRESS SPRINGS RD. Saratoga, CA 95070 |
Contact | George D Hermann |
Correspondent | George D Hermann STARION INSTRUMENTS 22900 CONGRESS SPRINGS RD. Saratoga, CA 95070 |
Product Code | HQP |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-05 |
Decision Date | 1999-06-03 |
Summary: | summary |