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FDA 510(k) Application Details - K213547
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K213547
Device Name
Condom
Applicant
TTK Healthcare Limited
12, K P Natham Road, Thiruvandar Koil,
Puducherry 605102 IN
Other 510(k) Applications for this Company
Contact
Daniel J S
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
HIS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/08/2021
Decision Date
12/23/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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