FDA 510(k) Application Details - K990242

Device Classification Name System, X-Ray, Stationary

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510(K) Number K990242
Device Name System, X-Ray, Stationary
Applicant I.Z.I. MEDICAL PRODUCTS CORP.
P.O. BOX 4341
CROFTON, MD 21114 US
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Contact E J SMITH
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 01/25/1999
Decision Date 03/03/1999
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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