The following data is part of a premarket notification filed by Starion Instruments with the FDA for Cautery Clamp And Battery Pack Power Supply.
Device ID | K992460 |
510k Number | K992460 |
Device Name: | CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | STARION INSTRUMENTS 22900 CONGRESS SPRINGS RD. Saratoga, CA 95070 |
Contact | George Hermann |
Correspondent | George Hermann STARION INSTRUMENTS 22900 CONGRESS SPRINGS RD. 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 | 1999-07-23 |
Decision Date | 1999-10-05 |
Summary: | summary |