FDA 510(k) Application Details - K850816

Device Classification Name Screen, Leaded, Operator Radiation Protector

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510(K) Number K850816
Device Name Screen, Leaded, Operator Radiation Protector
Applicant VICTOREEN, INC.
100 VOICE RD.
CARLE PLACE, NY US
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Contact GLASSER
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Regulation Number 892.6500

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Classification Product Code EAK
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Date Received 02/28/1985
Decision Date 04/10/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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