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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 K895945
Device Name KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE
Applicant
LASERSCOPE
3052 ORCHARD DR.
SAN JOSE,  CA  95134 -2011
Applicant Contact RICHARD P RUDY
Correspondent
LASERSCOPE
3052 ORCHARD DR.
SAN JOSE,  CA  95134 -2011
Correspondent Contact RICHARD P RUDY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/11/1989
Decision Date 04/09/1990
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
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