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510(k) K854430

RIGIDENT CREAM by Armkel, LLC — Product Code KOT

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

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  • K992232 — FIRST RESPONSE 1-STEP PREGNANCY (December 21, 1999)
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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)