Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K081853
Device Classification Name
Endoscopic Tissue Approximation Device
More FDA Info for this Device
510(K) Number
K081853
Device Name
Endoscopic Tissue Approximation Device
Applicant
APOLLO ENDOSURGERY, INC.
7000 BEE CAVES RD. SUITE 350
AUSTIN, TX 78746 US
Other 510(k) Applications for this Company
Contact
DENNIS MCWILLIAMS
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
OCW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2008
Decision Date
08/18/2008
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