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510(k) K854430

RIGIDENT CREAM by Armkel, LLC — Product Code KOT

K854430 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "RIGIDENT CREAM". The FDA issued a decision of Substantially Equivalent on March 4, 1986. The device falls under product code KOT (Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium), a Class I device regulated under 21 CFR 872.3490. Armkel, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
November 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
Device Class
Class I
Regulation Number
872.3490
Review Panel
DE
Submission Type

Other clearances by Armkel, LLC

  • K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST (October 19, 2004)
  • K030258 — FIRST RESPONSE PREGNANCY TEST (February 25, 2003)
  • K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS (December 16, 2002)
  • K013433 — TROJAN PASSION BERRY GEL (March 5, 2002)
  • K013614 — TROJAN CRYSTAL CLEAR LIQUID (February 1, 2002)
  • 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)

Other clearances for product code KOT

  • K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM (December 20, 1994)
  • K941365 — MPI DENTURE ADHESIVE FILM SEALS (April 22, 1994)
  • K903568 — SUPER STRENGTH DENTURE ADHESIVE CREAM (October 24, 1990)
  • K895818 — STEADFAST DENTURE ADHESIVE CREAM (April 3, 1990)
  • K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (November 1, 1988)
  • K872225 — SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER (June 30, 1987)
  • K831493 — DENTURE ADHESIVE SEALS (June 30, 1983)

FDA data resources