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510(k) K071691

DUAL SHOT ALPHA by Nemoto Kyorindo Co., Ltd. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2007
Date Received
June 20, 2007
Clearance Type
Special
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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  • K092896 — REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS (October 29, 2010)
  • K091734 — SONIC SHOT GX (May 21, 2010)
  • K062168 — CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA (August 18, 2006)
  • K052633 — DUAL SHOT - CONTRAST DELIVERY SYSTEM (October 17, 2005)

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