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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 K874934
Device Name UNIVERSAL EXAMINATION TABLE
Applicant
Imatron, Inc.
389 Oyster Point Blvd.
South San Fransisco,  CA  94080
Applicant Contact J. A CODUTO
Correspondent
Imatron, Inc.
389 Oyster Point Blvd.
South San Fransisco,  CA  94080
Correspondent Contact J. A CODUTO
Regulation Number892.1980
Classification Product Code
KXJ  
Date Received12/04/1987
Decision Date 01/19/1988
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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