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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 K912327
Device Name DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.
Applicant
Davis Lead Aprons, Inc.
1078 Curtin St.
Houston,  TX  77018
Applicant Contact J. B DAVIS
Correspondent
Davis Lead Aprons, Inc.
1078 Curtin St.
Houston,  TX  77018
Correspondent Contact J. B DAVIS
Regulation Number892.6500
Classification Product Code
KPY  
Date Received05/24/1991
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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