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510(k) K243584

0.04 ZERO ZERO FOUR Male Latex Condom by Okamoto USA, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2025
Date Received
November 20, 2024
Clearance Type
Abbreviated
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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