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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 K120870
Device Name GREENLIGHT MOXY FIBER OPTIC
Applicant
AMERICAN MEDICAL SYSTEMS
3070 ORCHARD DRIVE
SAN JOSE,  CA  95134
Applicant Contact DOREEN NAKAMURA
Correspondent
AMERICAN MEDICAL SYSTEMS
3070 ORCHARD DRIVE
SAN JOSE,  CA  95134
Correspondent Contact DOREEN NAKAMURA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/22/2012
Decision Date 06/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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