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510(k) K203541

Okamoto 002 Lubricated Polyurethane Male Condom by Okamoto USA, Inc. — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2022
Date Received
December 3, 2020
Clearance Type
Traditional
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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