Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K171139
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K171139
Device Name
Insufflator, Laparoscopic
Applicant
Buffalo Filter, LLC
5900 Genesee Street
Lancaster, NY 14086 US
Other 510(k) Applications for this Company
Contact
Kyrylo Shvetsov
Other 510(k) Applications for this Contact
Regulation Number
884.1730
More FDA Info for this Regulation Number
Classification Product Code
HIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/18/2017
Decision Date
05/18/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact