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510(k) K062168

CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA by Nemoto Kyorindo Co., Ltd. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2006
Date Received
July 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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  • K092896 — REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS (October 29, 2010)
  • K091734 — SONIC SHOT GX (May 21, 2010)
  • K071691 — DUAL SHOT ALPHA (December 19, 2007)
  • K052633 — DUAL SHOT - CONTRAST DELIVERY SYSTEM (October 17, 2005)

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