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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 K060764
Device Name SATURN 3 LASER SYSTEM
Applicant
RESEARCH INSTRUMENTS LTD.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
RESEARCH INSTRUMENTS LTD.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number884.6200
Classification Product Code
MRX  
Date Received03/21/2006
Decision Date 03/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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