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FDA 510(k) Application Details - K070545
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
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510(K) Number
K070545
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN, NJ 08558 US
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NADER FOTOUHI
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Regulation Number
884.5300
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Classification Product Code
NUC
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More FDA Info for this Product Code
Date Received
02/26/2007
Decision Date
03/23/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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