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510(k) K250034

Natural rubber latex male condom by Shaoguan Regenex Pharmaceuticals Co., Ltd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2025
Date Received
January 7, 2025
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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