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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K041667
Device Name SAN-MAR LABS LUBRICATING JELLY
Applicant
SAN-MAR LABORATORIES, INC.
4 WAREHOUSE LN.
ELMSFORD,  NY  10523
Applicant Contact SIMON SANDERS
Correspondent
SAN-MAR LABORATORIES, INC.
4 WAREHOUSE LN.
ELMSFORD,  NY  10523
Correspondent Contact SIMON SANDERS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/18/2004
Decision Date 01/13/2005
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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