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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Medium, Contrast, Radiologic
510(k) Number K800459
Device Name BARIUM SULFATE, USP IN SUSPENSION
Applicant
Central Pharmaceuticals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Central Pharmaceuticals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
KTA  
Date Received02/29/1980
Decision Date 05/30/1980
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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