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510(k) K052633

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2005
Date Received
September 26, 2005
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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  • K091734 — SONIC SHOT GX (May 21, 2010)
  • K071691 — DUAL SHOT ALPHA (December 19, 2007)
  • K062168 — CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA (August 18, 2006)

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