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510(k) K946376

MAXX by Mayer Laboratories — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1995
Date Received
December 14, 1994
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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  • K925869 — SHEATHES, STERILE SHEATHES (January 6, 1994)
  • K926049 — DIGITEX, DIGITEX HYPOALLERGENIC (July 22, 1993)
  • K904375 — KIMONO PLUS (November 26, 1990)
  • K904453 — LABELLING MODIFICATION TO MAXX PLUS (November 23, 1990)

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