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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 K010199
Device Name PJUR EROS WATER FORMULATION
Applicant
L.C.C. PJUR GROUP GERMANY
65 BANK ST.
SUITE #9
NEW YORK,  NY  10014
Applicant Contact RICHARD HARRIS
Correspondent
L.C.C. PJUR GROUP GERMANY
65 BANK ST.
SUITE #9
NEW YORK,  NY  10014
Correspondent Contact RICHARD HARRIS
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/22/2001
Decision Date 04/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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