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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 K942381
Device Name LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING
Applicant
APOGEE, INC.
7517-101 PRECISION DR.
RALEIGH,  NC  27613
Applicant Contact DIANE N PEPER
Correspondent
APOGEE, INC.
7517-101 PRECISION DR.
RALEIGH,  NC  27613
Correspondent Contact DIANE N PEPER
Regulation Number870.1650
Classification Product Code
DXT  
Date Received05/19/1994
Decision Date 03/17/1995
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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