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510(k) K904840

ORION PLUS/MODIFICATION by Mayer Laboratories — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1990
Date Received
October 24, 1990
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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  • K904375 — KIMONO PLUS (November 26, 1990)

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