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510(k) K844072

DERMIZIP SKIN CLOSURE DEVICE by Kells Medical, Inc.

K844072 is an FDA 510(k) premarket notification submitted by Kells Medical, Inc. for the device "DERMIZIP SKIN CLOSURE DEVICE". The FDA issued a decision of Substantially Equivalent on November 5, 1984. Kells Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1984
Date Received
October 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K832678 — PHONATORY FUNCTION ANALYZER PS-77 (March 7, 1984)
  • K832667 — LUCAE'S EAR & NASAL APPLICATORS (September 29, 1983)
  • K823118 — SAY (January 7, 1983)
  • K823226 — SN-100 DOCTOR'S ROUND (November 22, 1982)

FDA data resources