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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K001077
Device Name LUBRIGEL PERSONAL LUBRICANT
Applicant
Sheffield Laboratories, Div. of Faria Limited, LLC
170 Broad St.
New London,  CT  06320
Applicant Contact KATHLEEN HACKU
Correspondent
Sheffield Laboratories, Div. of Faria Limited, LLC
170 Broad St.
New London,  CT  06320
Correspondent Contact KATHLEEN HACKU
Regulation Number884.5300
Classification Product Code
NUC  
Date Received04/04/2000
Decision Date 08/02/2000
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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