FDA 510(k) Application Details - K962622

Device Classification Name Shield, Protective, Personnel

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510(K) Number K962622
Device Name Shield, Protective, Personnel
Applicant MEDTEC, INC.
1401 8TH ST., S.E.
P.O. BOX 320
ORANGE CITY, IA 51041-0320 US
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Contact DONALD F RIIBE
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Regulation Number 892.6500

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Classification Product Code KPY
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Date Received 07/05/1996
Decision Date 10/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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