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510(k) K213921

Microthin Natural Rubber Latex Condom by Suretex Limited — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2022
Date Received
December 15, 2021
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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