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510(k) K832667

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

K832667 is an FDA 510(k) premarket notification submitted by Kells Medical, Inc. for the device "LUCAE'S EAR & NASAL APPLICATORS". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code KCJ (Applicator, Ent), a Class I device regulated under 21 CFR 874.5220. Kells Medical, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K926333 — CPR PLUS (November 8, 1993)
  • K890093 — PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET (July 24, 1989)
  • K890094 — EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (May 24, 1989)
  • 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)
  • K823226 — SN-100 DOCTOR'S ROUND (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)

FDA data resources