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510(k) K210294

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2021
Date Received
February 2, 2021
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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