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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, cautery, thermal, ac-powered
510(k) Number K002341
Device Name THERMAL CAUTERY UNIT, MODEL 150
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 Number886.4115
Classification Product Code
HQO  
Date Received08/01/2000
Decision Date 10/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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