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FDA 510(k) Application Details - K962816
Device Classification Name
Condom, Synthetic
More FDA Info for this Device
510(K) Number
K962816
Device Name
Condom, Synthetic
Applicant
GENX INTL., INC.
339 BARTLETT DR.
MADISON, CT 06443 US
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Contact
MICHAEL D CECCHI
Other 510(k) Applications for this Contact
Regulation Number
884.5300
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Classification Product Code
MOL
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More FDA Info for this Product Code
Date Received
07/19/1996
Decision Date
11/26/1996
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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