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510(k) K875111

RUBBER CONTRACEPTIVE, LATEX CONDOMS by Okamoto USA, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1988
Date Received
December 14, 1987
Clearance Type
Traditional
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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