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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 K912422
Device Name SURG/ASSIST MODEL SA-1
Applicant
Surg-Assist, Inc.
10691 Champagne Rd.
Alta Loma,  CA  91701
Applicant Contact ANDREW P FRISQUE
Correspondent
Surg-Assist, Inc.
10691 Champagne Rd.
Alta Loma,  CA  91701
Correspondent Contact ANDREW P FRISQUE
Regulation Number878.5070
Classification Product Code
FYD  
Date Received05/31/1991
Decision Date 08/12/1991
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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