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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 K871911
Device Name THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION
Applicant
F. Spoon Co.
32 Grandhill Dr.
Dover,  MA  02030
Applicant Contact FRANCIS J SCHOLZ
Correspondent
F. Spoon Co.
32 Grandhill Dr.
Dover,  MA  02030
Correspondent Contact FRANCIS J SCHOLZ
Regulation Number892.1650
Classification Product Code
JAA  
Date Received05/18/1987
Decision Date 05/29/1987
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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