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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 K920100
Device Name GSU HANDPIECE ADAPTER
Applicant
BEACON LABORATORIES, INC.
2150 WEST 6TH AVE., UNIT P
BROOMFIELD,  CO  80020
Applicant Contact RICHARD FLEENOR
Correspondent
BEACON LABORATORIES, INC.
2150 WEST 6TH AVE., UNIT P
BROOMFIELD,  CO  80020
Correspondent Contact RICHARD FLEENOR
Regulation Number878.4400
Classification Product Code
HAM  
Date Received01/09/1992
Decision Date 02/03/1992
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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