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510(k) K863375

SEA-BOND by Combe, Inc. — Product Code KXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1986
Date Received
September 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
Device Class
Class I
Regulation Number
872.3450
Review Panel
DE
Submission Type

Other clearances by Combe, Inc.

  • K942203 — OTC DENTURE CLEANSER (August 10, 1994)
  • K925259 — CFR MONOGRAPH (January 11, 1993)
  • K780719 — FUNGUS FIGHTER INSOLES (October 10, 1978)
  • K770413 — CUSHIONS, DENTURE ADHESIVE, ALL-DAY (June 24, 1977)
  • K770175 — SEA-BOND ADHEVISE DENTURE CUSHIONS (February 4, 1977)