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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 K983216
Device Name CVS PERSONAL LUBRICANT
Applicant
San-Mar Laboratories, Inc.
4 Warehouse Ln.
Elmsford,  NY  10523
Applicant Contact IRWIN SILVERBERG
Correspondent
San-Mar Laboratories, Inc.
4 Warehouse Ln.
Elmsford,  NY  10523
Correspondent Contact IRWIN SILVERBERG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/14/1998
Decision Date 05/17/1999
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
Predetermined Change
Control Plan Authorized		 No
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