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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiologic
510(k) Number K820111
Device Name SIEMENS SIRESKOP 4
Applicant
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1980
Classification Product Code
KXJ  
Date Received01/15/1982
Decision Date 02/18/1982
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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