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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K851809
Device Name VACUUM COMPRESSION INJECTOR
Applicant
Uci Corp.
1150 17th. St.
Suite 1000
Washington,  DC  20036
Applicant Contact JOHN B DUBECK
Correspondent
Uci Corp.
1150 17th. St.
Suite 1000
Washington,  DC  20036
Correspondent Contact JOHN B DUBECK
Regulation Number880.5430
Classification Product Code
KZE  
Date Received04/26/1985
Decision Date 07/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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