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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 K003867
Device Name EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
Applicant
Biofilm, Inc.
3121 Scott St.
Vista,  CA  92083
Applicant Contact ROBERT L DE ARMOND
Correspondent
Biofilm, Inc.
3121 Scott St.
Vista,  CA  92083
Correspondent Contact ROBERT L DE ARMOND
Regulation Number884.5300
Classification Product Code
NUC  
Subsequent Product Code
MMS  
Date Received12/12/2000
Decision Date 03/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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