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510(k) K171213

One Touch Condom with Benzocaine by Thai Nippon Rubber Industry Public Company Limited. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2018
Date Received
April 25, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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