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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 K972575
Device Name 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES
Applicant
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134 -2011
Applicant Contact LISA MCGRATH
Correspondent
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134 -2011
Correspondent Contact LISA MCGRATH
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/10/1997
Decision Date 07/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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