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FDA 510(k) Application Details - K980109
Device Classification Name
Dispenser, Liquid Medication
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510(K) Number
K980109
Device Name
Dispenser, Liquid Medication
Applicant
SANGSTAT MEDICAL CORP.
6300 DUMBARTON CIRCLE
FREMONT, CA 94555 US
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Contact
DEREK WILLIAMS
Other 510(k) Applications for this Contact
Regulation Number
880.6430
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Classification Product Code
KYX
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More FDA Info for this Product Code
Date Received
01/12/1998
Decision Date
08/18/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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