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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Actuator, Syringe, Injector Type
510(k) Number K882723
Device Name ALCON FLUID INJECTOR
Applicant
Alcon Laboratories
6201 S. Fwy.
P.O. Box 6600
Fort Worth,  TX  76134
Applicant Contact REBECCA G WALKER
Correspondent
Alcon Laboratories
6201 S. Fwy.
P.O. Box 6600
Fort Worth,  TX  76134
Correspondent Contact REBECCA G WALKER
Regulation Number870.1670
Classification Product Code
DQF  
Date Received07/01/1988
Decision Date 11/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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