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510(k) K885136

GRAFT GUARD by Sorex Medical — Product Code LZM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1989
Date Received
December 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guard, Skin Graft
Device Class
Class I
Regulation Number
878.4014
Review Panel
SU
Submission Type

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  • K903740 — TRACH-EZE (December 6, 1990)
  • K902410 — MEDICAL PROCEDURE TRAY (November 20, 1990)

Other clearances for product code LZM

  • K943871 — AQUAPLAST TIE DOWN DRESSING (September 30, 1994)