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FDA 510(k) Application Details - K983017
Device Classification Name
Washer, Cleaner, Automated, Endoscope
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510(K) Number
K983017
Device Name
Washer, Cleaner, Automated, Endoscope
Applicant
CUSTOM ULTRASONICS
144 RAILROAD DR.
IVYLAND, PA 18974 US
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Contact
FRANK J WEBER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
NVE
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More FDA Info for this Product Code
Date Received
08/28/1998
Decision Date
09/22/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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