The following data is part of a premarket notification filed by Starion Instruments with the FDA for Thermal Cautery Probe.
Device ID | K050308 |
510k Number | K050308 |
Device Name: | THERMAL CAUTERY PROBE |
Classification | Apparatus, Cautery, Radiofrequency, Ac-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 | HQR |
CFR Regulation Number | 886.4100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-08 |
Decision Date | 2005-02-25 |
Summary: | summary |