Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K964482
Device Classification Name
Ureteroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K964482
Device Name
Ureteroscope And Accessories, Flexible/Rigid
Applicant
APPLIED FIBEROPTICS, INC.
122 CHARLTON ST.
SOUTHBRIDGE, MA 01550 US
Other 510(k) Applications for this Company
Contact
GRAHAM BAILLIE
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FGB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/08/1996
Decision Date
01/24/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact