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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 K050734
Device Name COOL.CLICK
Applicant
Bioject, Inc.
20245 SW 95th Ave.
Tualatin,  OR  97062
Applicant Contact MELANIE TALBERT
Correspondent
Bioject, Inc.
20245 SW 95th Ave.
Tualatin,  OR  97062
Correspondent Contact MELANIE TALBERT
Regulation Number880.5430
Classification Product Code
KZE  
Date Received03/21/2005
Decision Date 06/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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