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FDA 510(k) Application Details - K111791
Device Classification Name
Camera, Scintillation (Gamma)
More FDA Info for this Device
510(K) Number
K111791
Device Name
Camera, Scintillation (Gamma)
Applicant
GAMMA MEDICA-IDEAS INCORPORATED
755 N. MATHILDA AVENUE
SUITE 100
SUNNYVALE, CA 94085 US
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Contact
Albert Boniske
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Regulation Number
892.1100
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Classification Product Code
IYX
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More FDA Info for this Product Code
Date Received
06/27/2011
Decision Date
09/23/2011
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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