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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Protective, Personnel
510(k) Number K844160
Device Name VENTIBOX
Applicant
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Applicant Contact ELEANOR V CHIU
Correspondent
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Correspondent Contact ELEANOR V CHIU
Regulation Number892.6500
Classification Product Code
KPY  
Date Received10/24/1984
Decision Date 12/17/1984
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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