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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K971382
Device Name PRONE BREAST POSITIONING BOARD, MODEL #37-018
Applicant
Victoreen, Inc.
6000 Cochran Rd.
Solon,  OH  44139
Applicant Contact LINDA S NASH
Correspondent
Victoreen, Inc.
6000 Cochran Rd.
Solon,  OH  44139
Correspondent Contact LINDA S NASH
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/14/1997
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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