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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Table, Radiographic, Tilting
510(k) Number K892226
Device Name TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE
Applicant
Tecnomed, Inc.
235 S. Fehr Way
Bay Shore,  NY  11706
Applicant Contact JEAN GRISWOLD
Correspondent
Tecnomed, Inc.
235 S. Fehr Way
Bay Shore,  NY  11706
Correspondent Contact JEAN GRISWOLD
Regulation Number892.1980
Classification Product Code
IXR  
Date Received04/04/1989
Decision Date 04/26/1989
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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