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510(k) K915238

TRAC-WRIGHT TRAC 10 CATHETER by Dow Corning Wright — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1992
Date Received
November 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

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  • K930188 — ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT (August 3, 1993)
  • K930190 — ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP (August 2, 1993)

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