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FDA 510(k) Application Details - K181844
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K181844
Device Name
Condom
Applicant
Thai Nippon Rubber Industry Public Company Ltd
1 Charoenrat Road, Thungwatdon, Sathon
Bangkok 10120 TH
Other 510(k) Applications for this Company
Contact
Pisut Chanwatarungkull
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
07/11/2018
Decision Date
04/15/2019
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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