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510(k) K092896

REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS by Nemoto Kyorindo Co., Ltd. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2010
Date Received
September 21, 2009
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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