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510(k) K024324

LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 by Global Protection Corp. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2003
Date Received
December 26, 2002
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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