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510(k) K832667

LUCAE'S EAR & NASAL APPLICATORS by Kells Medical, Inc. — Product Code KCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
August 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Ent
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by Kells Medical, Inc.

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  • K890095 — PVC 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)
  • K823118 — SAY (January 7, 1983)
  • K823227 — IMPEDANCE METER ON-1 (November 22, 1982)

Other clearances for product code KCJ

  • K923679 — ENDOPATH TISSUE RETAINING COMPONENT (September 9, 1992)
  • K921053 — LAPAROMED LIGATING LOOP (August 6, 1992)
  • K894369 — APDYNE PHENOL APPLICATOR KIT (October 12, 1989)