FDA 510(k) Application Details - K023373

Device Classification Name Camera, Scintillation (Gamma)

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510(K) Number K023373
Device Name Camera, Scintillation (Gamma)
Applicant GVI TECHNOLOGY PARTNERS
1470 ENTERPRISE PKWY.
TWINSBURG, OH 44087 US
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Contact KEVIN M NURROCK
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Regulation Number 892.1100

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Classification Product Code IYX
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Date Received 10/08/2002
Decision Date 01/03/2003
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 N
Expedited Review



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