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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, assisted reproduction laser
510(k) Number K083208
Device Name SATURN ACTIVE LASER SYSTEM
Applicant
RESEARCH INSTRUMENTS LTD.
BICKLAND INDUSTRIAL PARK
FALMOUTH, CORNWALL,  GB TR11 4TA
Correspondent
RESEARCH INSTRUMENTS LTD.
BICKLAND INDUSTRIAL PARK
FALMOUTH, CORNWALL,  GB TR11 4TA
Regulation Number884.6200
Classification Product Code
MRX  
Date Received10/31/2008
Decision Date 08/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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