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FDA 510(k) Application Details - K210208
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K210208
Device Name
Condom
Applicant
Titan Condoms LLC
1950 Elkhorn Ct. Unit. 210
San Mateo, CA 94403 US
Other 510(k) Applications for this Company
Contact
Neville Muringayi
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
HIS
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More FDA Info for this Product Code
Date Received
01/26/2021
Decision Date
02/17/2022
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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