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510(k) K000038

INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED by Indus Medicare , Ltd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2000
Date Received
January 6, 2000
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 Indus Medicare , Ltd.

  • K022614 — INVIGRA (April 8, 2003)
  • K020223 — INVIGRA (March 4, 2002)
  • K000040 — INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED (March 21, 2000)
  • K000039 — INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED (March 21, 2000)
  • K993693 — INVIGRA (December 29, 1999)
  • K992438 — INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) (August 2, 1999)
  • K991374 — INVIGRA (June 15, 1999)

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