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510(k) K952415

DUREX, RAMSES, SHEIK by London International U.S. Holdings, Inc. — Product Code LTZ

K952415 is an FDA 510(k) premarket notification submitted by London International U.S. Holdings, Inc. for the device "DUREX, RAMSES, SHEIK". The FDA issued a decision of Substantially Equivalent on July 15, 1996. The device falls under product code LTZ (Condom With Nonoxynol-9), a Class II device regulated under 21 CFR 884.5310. London International U.S. Holdings, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1996
Date Received
May 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom With Nonoxynol-9
Device Class
Class II
Regulation Number
884.5310
Review Panel
OB
Submission Type

Other clearances by London International U.S. Holdings, Inc.

  • K953813 — LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS (July 22, 1996)

Other clearances for product code LTZ

  • K033163 — CAUTION CONDOMS (April 27, 2004)
  • K012969 — DOUBLE SPRINGERS NONOXNOL 9 CONDOM (June 12, 2002)
  • K010178 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (April 27, 2001)
  • K003375 — CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX (January 28, 2001)
  • K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 (August 8, 2000)
  • K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (June 8, 2000)
  • K992438 — INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) (August 2, 1999)
  • K991047 — HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) (June 18, 1999)
  • K990669 — MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) (May 17, 1999)
  • K981955 — MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS (March 15, 1999)

FDA data resources