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510(k) K974324

LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT by Reddy Medtech Health Products , Ltd. — Product Code LTZ

K974324 is an FDA 510(k) premarket notification submitted by Reddy Medtech Health Products , Ltd. for the device "LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT". The FDA issued a decision of Substantially Equivalent on February 9, 1998. The device falls under product code LTZ (Condom With Nonoxynol-9), a Class II device regulated under 21 CFR 884.5310. Reddy Medtech Health Products , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1998
Date Received
November 18, 1997
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 Reddy Medtech Health Products , Ltd.

  • K980019 — HTL MALE CONDOM (April 1, 1998)
  • K974323 — LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT (February 10, 1998)
  • K974326 — LATEX CONDOMS (NATURAL COLOUR) (February 9, 1998)

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