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510(k) K823118

SAY by Kells Medical, Inc. — Product Code ESE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
October 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Larynx, Artificial (Battery-Powered)
Device Class
Class I
Regulation Number
874.3375
Review Panel
EN
Submission Type

Other clearances by Kells Medical, Inc.

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  • K890094 — EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (May 24, 1989)
  • K861972 — DERMISTRIP (June 27, 1986)
  • K844463 — DERMIDRESS (January 8, 1985)
  • K844072 — DERMIZIP SKIN CLOSURE DEVICE (November 5, 1984)
  • K832678 — PHONATORY FUNCTION ANALYZER PS-77 (March 7, 1984)
  • K832667 — LUCAE'S EAR & NASAL APPLICATORS (September 29, 1983)
  • K823227 — IMPEDANCE METER ON-1 (November 22, 1982)

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  • K860992 — VOX COMPANION (May 2, 1986)
  • K860993 — P.O. VOX (April 25, 1986)
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  • K840892 — ELECTRO-PALATE (May 22, 1984)
  • K834555 — BEAR VENTI--VOICE (January 24, 1984)