FDA 510(k) Application Details - K896949

Device Classification Name Screen, Leaded, Operator Radiation Protector

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510(K) Number K896949
Device Name Screen, Leaded, Operator Radiation Protector
Applicant INNOVATIVE PRODUCTS MFG.
BOX 447
248 DODGE AVENUE
EAST HAVEN, CT US
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Contact KENNEY, SR
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Regulation Number 892.6500

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Classification Product Code EAK
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Date Received 12/13/1989
Decision Date 02/16/1990
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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