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510(k) K780719

FUNGUS FIGHTER INSOLES by Combe, Inc. — Product Code KYS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
May 1, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insoles, Medical
Device Class
Class I
Regulation Number
880.6280
Review Panel
HO
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)
  • K770413 — CUSHIONS, DENTURE ADHESIVE, ALL-DAY (June 24, 1977)
  • K770175 — SEA-BOND ADHEVISE DENTURE CUSHIONS (February 4, 1977)