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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K992460
Device Name CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY
Applicant
Starion Instruments
22900 Congress Springs Rd.
Saratoga,  CA  95070
Applicant Contact GEORGE HERMANN
Correspondent
Starion Instruments
22900 Congress Springs Rd.
Saratoga,  CA  95070
Correspondent Contact GEORGE HERMANN
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HQP  
Date Received07/23/1999
Decision Date 10/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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