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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K895546
Device Name MODIFIED SPANTRON FRAME FREEZE
Applicant
Spantron, Inc.
Suite 373
3380 Sheridan Dr.
Amherst,  NY  14226
Applicant Contact STEPHEN RUDIN
Correspondent
Spantron, Inc.
Suite 373
3380 Sheridan Dr.
Amherst,  NY  14226
Correspondent Contact STEPHEN RUDIN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received09/13/1989
Decision Date 11/13/1989
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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