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510(k) K000748

TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT by Armkel, LLC — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2000
Date Received
March 8, 2000
Clearance Type
Special
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)
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  • 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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