Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K980795
Device Classification Name
Dilator, Catheter, Ureteral
More FDA Info for this Device
510(K) Number
K980795
Device Name
Dilator, Catheter, Ureteral
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
Other 510(k) Applications for this Company
Contact
LINDA S POLLITZ
Other 510(k) Applications for this Contact
Regulation Number
876.5470
More FDA Info for this Regulation Number
Classification Product Code
EZN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/02/1998
Decision Date
04/22/1998
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact