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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 K955681
Device Name AARON 800 HIGH FREQUENCY DESICCATOR/HANDPIECE
Applicant
Geiger Instrument Co., Inc.
24040 Camino Del Avion, A-195
Monarch Beach,  CA  92629
Applicant Contact JOHN BOTTJER
Correspondent
Geiger Instrument Co., Inc.
24040 Camino Del Avion, A-195
Monarch Beach,  CA  92629
Correspondent Contact JOHN BOTTJER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/14/1995
Decision Date 02/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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