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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 K912378
Device Name DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS
Applicant
Davis Lead Aprons, Inc.
1078 Curtin St.
Houston,  TX  77018
Applicant Contact DAVIS
Correspondent
Davis Lead Aprons, Inc.
1078 Curtin St.
Houston,  TX  77018
Correspondent Contact DAVIS
Regulation Number892.6500
Classification Product Code
KPY  
Date Received05/29/1991
Decision Date 03/18/1992
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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