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FDA 510(k) Application Details - K000905
Device Classification Name
Urethrotome
More FDA Info for this Device
510(K) Number
K000905
Device Name
Urethrotome
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS, IL 60061 US
Other 510(k) Applications for this Company
Contact
ROBERT L CASARSA
Other 510(k) Applications for this Contact
Regulation Number
876.4770
More FDA Info for this Regulation Number
Classification Product Code
EZO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2000
Decision Date
05/12/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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