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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K011265
Device Name ULTRASOUND TRANSDUCER COVER
Applicant
ADVANCE MEDICAL DESIGNS, INC.
1241 ATLANTA INDUSTRIAL DR.
marietta,  GA  30066
Applicant Contact bill gill
Correspondent
ADVANCE MEDICAL DESIGNS, INC.
1241 ATLANTA INDUSTRIAL DR.
marietta,  GA  30066
Correspondent Contact bill gill
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/25/2001
Decision Date 10/30/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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