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FDA 510(k) Application Details - K102748
Device Classification Name
Coil, Magnetic Resonance, Specialty
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510(K) Number
K102748
Device Name
Coil, Magnetic Resonance, Specialty
Applicant
RAPID BIOMEDICAL GMBH
KETTELERSTR. 3-11
TECHNOLOGIEPARK WUERZBURG-RIMP
RIMPAR, BAVARIA 97222 DE
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ARMIN PUREA
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Regulation Number
892.1000
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Classification Product Code
MOS
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More FDA Info for this Product Code
Date Received
09/23/2010
Decision Date
05/13/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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