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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K942116
Device Name SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)
Applicant
Siemens Corp.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Applicant Contact IRENA KRUTULIS
Correspondent
Siemens Corp.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Correspondent Contact IRENA KRUTULIS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/03/1994
Decision Date 07/29/1994
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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