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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, electrosurgical
510(k) Number K894762
Device Name B100 DISPOSABLE HANDPIECE
Applicant
BEACON LABORATORIES, INC.
11256 QUIVAS LOOP
WESTMINSTER,  CO  80234
Applicant Contact RICHARD P FLEENOR
Correspondent
BEACON LABORATORIES, INC.
11256 QUIVAS LOOP
WESTMINSTER,  CO  80234
Correspondent Contact RICHARD P FLEENOR
Regulation Number878.4400
Classification Product Code
HAM  
Date Received07/27/1989
Decision Date 09/15/1989
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
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