The following data is part of a premarket notification filed by Starion Instruments with the FDA for Starion Universal Power Supply (ups).
Device ID | K043155 |
510k Number | K043155 |
Device Name: | STARION UNIVERSAL POWER SUPPLY (UPS) |
Classification | Unit, Cautery, Thermal, 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 | HQO |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-15 |
Decision Date | 2004-12-09 |
Summary: | summary |