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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K874512
Device Name MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM
Applicant
Stackhouse Assoc.
Box 164
Manhattan Beach,  CA  90266
Applicant Contact H STACKHOUSE
Correspondent
Stackhouse Assoc.
Box 164
Manhattan Beach,  CA  90266
Correspondent Contact H STACKHOUSE
Regulation Number878.5070
Classification Product Code
FYD  
Date Received11/02/1987
Decision Date 01/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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