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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K092896
Device Name REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS
Applicant
Nemoto Kyorindo Co., Ltd.
2-12-4 Aoki
Kawaguchi-Shi, Saitama,  JP 332-0031
Applicant Contact JIM KNIPFER
Correspondent
Nemoto Kyorindo Co., Ltd.
2-12-4 Aoki
Kawaguchi-Shi, Saitama,  JP 332-0031
Correspondent Contact JIM KNIPFER
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/21/2009
Decision Date 10/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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