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510(k) K942526

SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM by Life Medical Sciences, Inc. — Product Code MKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1994
Date Received
May 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Skin Closure
Device Class
Class I
Regulation Number
878.4320
Review Panel
SU
Submission Type

Other clearances by Life Medical Sciences, Inc.

  • K980563 — SKAR-KARE SHEET (May 20, 1998)
  • K926127 — SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM (June 24, 1993)

Other clearances for product code MKY

  • K002315 — WISEBANDS SKIN CLOSURE DEVICE (March 15, 2001)
  • K982439 — PROXIDERM, MODELS TN 460, TN 90 460, BK 460 (September 8, 1998)
  • K970439 — PROXIDERM (D-460,D 90 460,D 180,460, PS 460) (April 16, 1997)
  • K962144 — PHOENIX ETE TISSUE EXTENSION SYSTEM (January 14, 1997)
  • K942425 — PROXIDERM (TENTATIVE) (November 4, 1994)