The following data is part of a premarket notification filed by Starion Instruments with the FDA for Starion Instruments Power Point Cautery Grasper/dissector.
Device ID | K002547 |
510k Number | K002547 |
Device Name: | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR |
Classification | Unit, Cautery, Thermal, Battery-powered |
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 | HQP |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-17 |
Decision Date | 2000-10-20 |