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510(k) K023405

TROJAN MINT TINGLE BRAND LATEX CONDOMS by Armkel, LLC — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2002
Date Received
October 10, 2002
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 Armkel, LLC

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  • K001212 — TROJAN EXTRA LARGE LATEX CONDOM (May 9, 2000)
  • K000748 — TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT (April 6, 2000)
  • K992232 — FIRST RESPONSE 1-STEP PREGNANCY (December 21, 1999)
  • K973352 — BRAND NAME *1-STEP PREGNANCY (October 27, 1997)
  • K973310 — TBD* ONE-STEP OVULATION PREDICTOR TEST (October 27, 1997)
  • K963318 — LEGIONELLA IGG/IGM ELISA TEST SYSTEM (March 3, 1997)

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