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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apron, Leaded
510(k) Number K931269
Device Name LEAD APRON
Applicant
Bt Medical Co., Inc.
Second And Depot
Bridgeport,  PA  19405
Applicant Contact BUCKLEY THOMPSON
Correspondent
Bt Medical Co., Inc.
Second And Depot
Bridgeport,  PA  19405
Correspondent Contact BUCKLEY THOMPSON
Regulation Number892.6500
Classification Product Code
EAJ  
Date Received03/08/1993
Decision Date 06/02/1993
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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