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510(k) K811428

NORTHWESTERN VOICE RESTORATION KIT by Universal Prosthetics, Inc. — Product Code KAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1981
Date Received
May 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Laryngectomy
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Universal Prosthetics, Inc.

  • K832366 — ZOLLER BURNED LIP CONFORMER (September 26, 1983)
  • K813132 — THE CHICAGO GULLET (January 7, 1982)

Other clearances for product code KAC

  • K901377 — BARTON-MAYO TRACHEOSTOMA BUTTON (June 14, 1990)
  • K873992 — LARYNGECTOMY TUBE (March 24, 1988)
  • K821993 — SHILEY LARYNGECTOMY TUBE (August 12, 1982)