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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Indicator
510(k) Number K760448
Device Name SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT
Applicant
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1660
Classification Product Code
DXL  
Date Received08/16/1976
Decision Date 08/27/1976
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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