FDA 510(k) Application Details - K052473

Device Classification Name Camera, Scintillation (Gamma)

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510(K) Number K052473
Device Name Camera, Scintillation (Gamma)
Applicant INTER MEDICAL MEDIZINTECHNIK GMBH
DAIMLERSTRASSE 34-36
LUEBBECKE D-32312 DE
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Contact HANS GUENTER OSIEK
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Regulation Number 892.1100

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Classification Product Code IYX
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Date Received 09/09/2005
Decision Date 10/28/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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