Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K990515
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K990515
Device Name
Instrument, Biopsy
Applicant
INTERNATIONAL MEDICAL SYSTEMS
PO BOX 4936
ANNAPOLIS, MD 21403 US
Other 510(k) Applications for this Company
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
02/18/1999
Decision Date
05/13/1999
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