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510(k) K823226

SN-100 DOCTOR'S ROUND by Kells Medical, Inc. — Product Code ETF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1982
Date Received
October 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
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)
  • K823118 — SAY (January 7, 1983)

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  • K910243 — MOBILE TREATMENT CART (April 17, 1991)
  • K896273 — SYSTEMA ENT CABINET (January 26, 1990)
  • K896298 — JEDMED S CHAIR (January 26, 1990)
  • K881958 — JEDMED MAXIM ENT CABINET (July 15, 1988)
  • K860940 — MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (May 2, 1986)