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510(k) K033163

CAUTION CONDOMS by Richard Van Haussen America, Inc. — Product Code LTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2004
Date Received
November 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom With Nonoxynol-9
Device Class
Class II
Regulation Number
884.5310
Review Panel
OB
Submission Type

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