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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 K811843
Device Name BIOPSY TRANSDUCER
Applicant
Siemens Gammasonics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Siemens Gammasonics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/01/1981
Decision Date 08/25/1981
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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