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510(k) K960430

CONTROL SYRINGE by Scientific Device Manufacturer, LLC — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1996
Date Received
January 31, 1996
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

Other clearances by Scientific Device Manufacturer, LLC

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  • K960431 — PRESSURE STOPCOCK/MANIFOLD (October 29, 1996)
  • K961290 — IUP - TIP TRANS, IUP - PROXI TRANS (October 15, 1996)
  • K960917 — PERCUGLIDE (July 2, 1996)
  • K952579 — TOCO TRANSDUCER (August 4, 1995)

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