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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, stationary top
510(k) Number K973842
Device Name CARBON FIBER CONFORMAL COUCH TOP
Applicant
MEDTEC, INC.
1401 8TH ST. S.E.
P.O. BOX 602
ORANGE CITY,  IA  51041
Applicant Contact DONALD F RIIBE
Correspondent
MEDTEC, INC.
1401 8TH ST. S.E.
P.O. BOX 602
ORANGE CITY,  IA  51041
Correspondent Contact DONALD F RIIBE
Regulation Number892.1980
Classification Product Code
IXQ  
Date Received10/08/1997
Decision Date 12/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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