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510(k) K860925

DERMASPANDERE by Mri Ventures, Inc. — Product Code GFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1986
Date Received
March 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dermatome
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

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  • K940208 — AESCULAP ACCU-DERMATOME (February 24, 1994)
  • K862669 — ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (October 3, 1986)
  • K861285 — SKIN MESH DEVICE (April 17, 1986)
  • K861138 — MASH DERMATOME (April 14, 1986)
  • K842702 — ROSENBERG SKIN GRAFTING KNIVES (August 2, 1984)
  • K830993 — AMPLIGREFFE (May 3, 1983)