Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K143546
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K143546
Device Name
Instrument, Biopsy
Applicant
Stryker Corporation
2 Pearl Court
Allendale, NJ 07401 US
Other 510(k) Applications for this Company
Contact
Soraya King
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2014
Decision Date
03/19/2015
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