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510(k) K222611

Male Latex Condoms by Suzhou Colour-Way New Material Co., Ltd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2022
Date Received
August 30, 2022
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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