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510(k) K770413

CUSHIONS, DENTURE ADHESIVE, ALL-DAY by Combe, Inc. — Product Code EHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1977
Date Received
March 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cushion, Denture, Over The Counter
Device Class
Class II
Regulation Number
872.3540
Review Panel
DE
Submission Type

Other clearances by Combe, Inc.

  • K942203 — OTC DENTURE CLEANSER (August 10, 1994)
  • K925259 — CFR MONOGRAPH (January 11, 1993)
  • K863375 — SEA-BOND (September 19, 1986)
  • K780719 — FUNGUS FIGHTER INSOLES (October 10, 1978)
  • K770175 — SEA-BOND ADHEVISE DENTURE CUSHIONS (February 4, 1977)

Other clearances for product code EHS

  • K971002 — SMILE WITH CONFIDENCE (July 15, 1997)
  • K813190 — SOFT PLATE CUSHION (February 5, 1982)