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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 K953610
Device Name AUKULYTE
Applicant
Aukland Medical Plastics, Inc.
P.O. Box 5624
Cary,  NC  27512
Applicant Contact NORMAN A GRAY
Correspondent
Aukland Medical Plastics, Inc.
P.O. Box 5624
Cary,  NC  27512
Correspondent Contact NORMAN A GRAY
Regulation Number892.6500
Classification Product Code
KPY  
Date Received08/02/1995
Decision Date 09/26/1995
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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