FDA 510(k) Application Details - K000052

Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic

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510(K) Number K000052
Device Name Assembly, Tube Housing, X-Ray, Diagnostic
Applicant DYNARAD CORP.
19 JEFRYN BLVD. WEST
DEER PARK, NY 11729 US
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Contact RAYMONF MANEZ
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Regulation Number 892.1760

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Classification Product Code ITY
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Date Received 01/07/2000
Decision Date 02/10/2000
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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