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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 K955684
Device Name RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
Applicant
Contour Fabricators of Florida, Inc.
1247 Florida Ave.
Palm Harobor,  FL  34683
Applicant Contact PATRICK J LAMB
Correspondent
Contour Fabricators of Florida, Inc.
1247 Florida Ave.
Palm Harobor,  FL  34683
Correspondent Contact PATRICK J LAMB
Regulation Number870.1650
Classification Product Code
DXT  
Date Received12/14/1995
Decision Date 05/02/1996
Decision Substantially Equivalent - Kit (SESK)
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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