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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K935209
Device Name INSTA-FLO
Applicant
Medtec, Inc.
1401 8th St. SE
P.O. Box 602
Orange City,  IA  51041
Applicant Contact DONALD RIIBE
Correspondent
Medtec, Inc.
1401 8th St. SE
P.O. Box 602
Orange City,  IA  51041
Correspondent Contact DONALD RIIBE
Regulation Number892.5900
Classification Product Code
JAD  
Date Received10/29/1993
Decision Date 12/13/1993
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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