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510(k) K050957

EUTROCHAR by Special Devices, Inc. — Product Code MDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2005
Date Received
April 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Special Devices, Inc.

  • K982354 — SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT (November 23, 1998)

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  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K943968 — TUNNELER (March 1, 1995)
  • K945430 — DERMAVBLADE(TM) (November 28, 1994)