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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 K912651
Device Name AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM
Applicant
Stackhouse Assoc.
2059 Atlanta Ave.
Riverside,  CA  92507
Applicant Contact RICHARD J GREFF
Correspondent
Stackhouse Assoc.
2059 Atlanta Ave.
Riverside,  CA  92507
Correspondent Contact RICHARD J GREFF
Regulation Number878.5070
Classification Product Code
FYD  
Date Received06/17/1991
Decision Date 07/08/1991
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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