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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K812616
Device Name POLYPHOS 500
Applicant
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1700
Classification Product Code
IZO  
Date Received09/15/1981
Decision Date 10/13/1981
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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