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510(k) K192669

Extremely Thin 003, ZERO ZERO THREE by Okamoto USA, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2020
Date Received
September 25, 2019
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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