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FDA 510(k) Application Details - K203536
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K203536
Device Name
Condom
Applicant
Global Protection Corp.
12 Channel Street
Boston, MA 02210 US
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Contact
Christina Cataldo
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Regulation Number
884.5300
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Classification Product Code
HIS
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More FDA Info for this Product Code
Date Received
12/03/2020
Decision Date
09/03/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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