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510(k) K880877

CONTRAST INJECTION DEVICE by Med-West, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1988
Date Received
March 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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  • K831401 — SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS (June 3, 1983)
  • K831440 — SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 (June 3, 1983)

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