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510(k) K020659

DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT by Ssl Americas, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2002
Date Received
March 1, 2002
Clearance Type
Special
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 Ssl Americas, Inc.

  • K072169 — DUREX SYNTHETIC POLYISOPRENE MALE CONDOM (June 19, 2008)
  • K072236 — DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT (May 7, 2008)
  • K071626 — DUREX PLAY SOFT & SENSUAL LUBRICANT (April 1, 2008)
  • K063385 — DUREX PLAY MASSAGE GEL LUBRICANT (March 10, 2008)
  • K060098 — DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS (June 8, 2006)
  • K052959 — DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS (January 27, 2006)
  • K042958 — DUREX PLAY TINGLING LUBRICANT (April 8, 2005)
  • K042470 — DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDO (April 5, 2005)
  • K042563 — DUREX PLAY WARMER LUBRICANT (February 23, 2005)
  • K042957 — DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT (February 17, 2005)

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