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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 K983852
Device Name BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429
Applicant
Geiger Medical Technologies, Inc.
24040 Camino Del Avion, A-195
Monarch Beach,  CA  92629
Applicant Contact JOHN BOTTJER
Correspondent
Geiger Medical Technologies, Inc.
24040 Camino Del Avion, A-195
Monarch Beach,  CA  92629
Correspondent Contact JOHN BOTTJER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/30/1998
Decision Date 01/28/1999
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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