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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 K941831
Device Name LUBRICATING JELLY
Applicant
Barre-National, Inc.
333 Cassell Dr.
Suite 3500
Baltimore,  MD  21224
Applicant Contact DEBORAH WINKEL
Correspondent
Barre-National, Inc.
333 Cassell Dr.
Suite 3500
Baltimore,  MD  21224
Correspondent Contact DEBORAH WINKEL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/13/1994
Decision Date 01/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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