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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
Predetermined Change
Control Plan Authorized		 No
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