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510(k) K904453

LABELLING MODIFICATION TO MAXX PLUS by Mayer Laboratories — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1990
Date Received
September 27, 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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  • K943064 — KIMONO (CONDOMS) (September 22, 1995)
  • K925869 — SHEATHES, STERILE SHEATHES (January 6, 1994)
  • K926049 — DIGITEX, DIGITEX HYPOALLERGENIC (July 22, 1993)
  • K904375 — KIMONO PLUS (November 26, 1990)

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