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FDA 510(k) Application Details - K052704
Device Classification Name
Coil, Magnetic Resonance, Specialty
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510(K) Number
K052704
Device Name
Coil, Magnetic Resonance, Specialty
Applicant
INVIVO CORP.
N27 W23676 PAUL ROAD
PEWAUKEE, WI 53072 US
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Contact
THOMAS E TYNES
Other 510(k) Applications for this Contact
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
09/28/2005
Decision Date
11/03/2005
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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