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510(k) K884469

ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS by Mayer Laboratories — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1989
Date Received
October 25, 1988
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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