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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, Non-Tilting, Powered
510(k) Number K952701
Device Name MED-TRON SPECT IMAGING TABLE
Applicant
Med-Tron Products, Inc.
600 D N. Bicycle Path
Port Jefferson Sta.,  NY  11776
Applicant Contact LAWRENCE BONITCH
Correspondent
Med-Tron Products, Inc.
600 D N. Bicycle Path
Port Jefferson Sta.,  NY  11776
Correspondent Contact LAWRENCE BONITCH
Regulation Number892.1980
Classification Product Code
IZZ  
Date Received06/13/1995
Decision Date 07/06/1995
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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