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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Leaded, Operator Radiation Protector
510(k) Number K952233
Device Name CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628
Applicant
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Applicant Contact LINDA S MORIN
Correspondent
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Correspondent Contact LINDA S MORIN
Regulation Number892.6500
Classification Product Code
EAK  
Date Received05/12/1995
Decision Date 06/16/1995
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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