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FDA 510(k) Application Details - K182438
Device Classification Name
Condom, Synthetic
More FDA Info for this Device
510(K) Number
K182438
Device Name
Condom, Synthetic
Applicant
Sxwell Usa LLC
111 Wood Avenue South
Iselin, NJ 08830 US
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Contact
Robert Mahler
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
09/07/2018
Decision Date
12/06/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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