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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Protective, Personnel
510(k) Number K954456
Device Name THERMOPLASTIC SHIELD
Applicant
Medtec, Inc.
P.O. Box 487
1401 8th St. S. E.
Orange City,  IA  51041 -0487
Applicant Contact DONALD F RIIBE
Correspondent
Medtec, Inc.
P.O. Box 487
1401 8th St. S. E.
Orange City,  IA  51041 -0487
Correspondent Contact DONALD F RIIBE
Regulation Number892.6500
Classification Product Code
KPY  
Date Received09/25/1995
Decision Date 12/21/1995
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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