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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K904629
Device Name CENTAURI YAG LASER SYST, UROLOGY
Applicant
Pfizer Laser Systems
3 Morgan
Irvine,  CA  92718
Applicant Contact COZEAN, PH.D
Correspondent
Pfizer Laser Systems
3 Morgan
Irvine,  CA  92718
Correspondent Contact COZEAN, PH.D
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/09/1990
Decision Date 01/07/1991
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
Predetermined Change
Control Plan Authorized		 No
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