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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 K926407
Device Name MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM
Applicant
Nucletron-Oldelft Corp.
Box 786
Urbanna,  VA  23175
Applicant Contact DAVID P ARMSTRONG
Correspondent
Nucletron-Oldelft Corp.
Box 786
Urbanna,  VA  23175
Correspondent Contact DAVID P ARMSTRONG
Regulation Number892.1980
Classification Product Code
KXJ  
Date Received12/21/1992
Decision Date 03/31/1993
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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