Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K100712
Device Classification Name
Kit, Needle, Biopsy
More FDA Info for this Device
510(K) Number
K100712
Device Name
Kit, Needle, Biopsy
Applicant
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
Other 510(k) Applications for this Company
Contact
ASHLEY PYLE
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
FCG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/12/2010
Decision Date
03/30/2010
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
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact