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FDA 510(k) Application Details - K222068
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K222068
Device Name
Condom
Applicant
RB Health (US) LLC
399 Interpace Parkway
Parsippany, NJ 07054 US
Other 510(k) Applications for this Company
Contact
Kyle Prince
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
07/14/2022
Decision Date
10/12/2022
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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