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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culdoscope (And Accessories)
510(k) Number K110819
Device Name SINGHMED ROOLIP MANIPULATOR
Applicant
J.SINGH INSTRUMENTS
611 WEST 5TH STREET
3RD FLOOR
AUSTIN,  TX  78701
Applicant Contact CAROLINE TONTINI
Correspondent
J.SINGH INSTRUMENTS
611 WEST 5TH STREET
3RD FLOOR
AUSTIN,  TX  78701
Correspondent Contact CAROLINE TONTINI
Regulation Number884.1640
Classification Product Code
HEW  
Subsequent Product Code
LKF  
Date Received03/23/2011
Decision Date 10/05/2011
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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