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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 K880890
Device Name THE S.A.F.E. SYSTEM
Applicant
Pfizer Laser Systems
3 Morgan
Irvine,  CA  92718
Applicant Contact LINDA DIBENEDETTO
Correspondent
Pfizer Laser Systems
3 Morgan
Irvine,  CA  92718
Correspondent Contact LINDA DIBENEDETTO
Regulation Number878.5070
Classification Product Code
FYD  
Date Received03/02/1988
Decision Date 05/11/1988
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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