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510(k) K232470

Polyisoprene Extra Large Condom by Suretex Limited — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2024
Date Received
August 16, 2023
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

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