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FDA 510(k) Application Details - K982442
Device Classification Name
Probe, Uptake, Nuclear
More FDA Info for this Device
510(K) Number
K982442
Device Name
Probe, Uptake, Nuclear
Applicant
CARE WISE MEDICAL PRODUCTS CORP.
P.O. BOX 1655
MORGAN HILL, CA 95038-1655 US
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Contact
ROBIN A WISE
Other 510(k) Applications for this Contact
Regulation Number
892.1320
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Classification Product Code
IZD
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More FDA Info for this Product Code
Date Received
07/14/1998
Decision Date
08/25/1998
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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