FDA 510(k) Application Details - K944445

Device Classification Name Screen, Leaded, Operator Radiation Protector

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510(K) Number K944445
Device Name Screen, Leaded, Operator Radiation Protector
Applicant MED CORP.
101 N. DAYON
PO BOX 50010
AMES, IA US
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Contact WILLIAM R TOUT
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Regulation Number 892.6500

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Classification Product Code EAK
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Date Received 09/12/1994
Decision Date 05/11/1995
Decision SE - Substantially Equivalent
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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