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510(k) K113686

KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED by Mayer Laboratories, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2012
Date Received
December 15, 2011
Clearance Type
Abbreviated
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

Other clearances by Mayer Laboratories, Inc.

  • K130345 — AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING (August 1, 2013)
  • K110325 — AQUA LUBE (December 8, 2011)
  • K001974 — EZ-ON CONDOM (October 24, 2001)
  • K946374 — KIMONO MICROTHIN (November 8, 1995)
  • K946376 — MAXX (September 22, 1995)
  • 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)
  • K904453 — LABELLING MODIFICATION TO MAXX PLUS (November 23, 1990)

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