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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 K873597
Device Name TUBING, POLYETHYLENE
Applicant
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Applicant Contact PRISCILLA DENSMORE
Correspondent
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Correspondent Contact PRISCILLA DENSMORE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/04/1987
Decision Date 11/12/1987
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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