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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K914199
Device Name ANGIOGRAPHIC SOFT TIP CATHETER
Applicant
E-Z-Em, Inc.
P.O. Box 993
266 Queensbury Ave.
Glens Falls,  NY  12801
Applicant Contact MERRIBETH ADAMS
Correspondent
E-Z-Em, Inc.
P.O. Box 993
266 Queensbury Ave.
Glens Falls,  NY  12801
Correspondent Contact MERRIBETH ADAMS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/19/1991
Decision Date 12/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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