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510(k) K992438

INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) by Indus Medicare , Ltd. — Product Code LTZ

K992438 is an FDA 510(k) premarket notification submitted by Indus Medicare , Ltd. for the device "INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)". The FDA issued a decision of Substantially Equivalent on August 2, 1999. The device falls under product code LTZ (Condom With Nonoxynol-9), a Class II device regulated under 21 CFR 884.5310. Indus Medicare , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1999
Date Received
July 22, 1999
Clearance Type
Abbreviated
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 Indus Medicare , Ltd.

  • K022614 — INVIGRA (April 8, 2003)
  • K020223 — INVIGRA (March 4, 2002)
  • K000039 — INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED (March 21, 2000)
  • K000038 — INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED (March 21, 2000)
  • K000040 — INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED (March 21, 2000)
  • K993693 — INVIGRA (December 29, 1999)
  • K991374 — INVIGRA (June 15, 1999)

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)
  • 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)
  • K981621 — ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (June 19, 1998)

FDA data resources