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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Syringe, Lead
510(k) Number K934549
Device Name ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
Applicant
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130 -3304
Applicant Contact CHRISTINE L JESS
Correspondent
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130 -3304
Correspondent Contact CHRISTINE L JESS
Regulation Number892.6500
Classification Product Code
IWR  
Date Received09/22/1993
Decision Date 02/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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