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FDA 510(k) Application Details - K020827
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K020827
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC.
199 GRANDVIEW RD.
SKILLMAN, NJ 08558-9418 US
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Contact
MARYLOU PANICO
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Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
NUC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/14/2002
Decision Date
06/12/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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