FDA 510(k) Application Details - K944772

Device Classification Name Screen, Leaded, Operator Radiation Protector

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510(K) Number K944772
Device Name Screen, Leaded, Operator Radiation Protector
Applicant IMAGE DIAGNOSTICS, INC.
98 PRATTS JUNCTION RD.
STERLING, MA US
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Contact REMO J ROSSI
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Regulation Number 892.6500

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Classification Product Code EAK
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Date Received 09/27/1994
Decision Date 10/20/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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