Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K023843
Device Classification Name
Endoscopic Tissue Approximation Device
More FDA Info for this Device
510(K) Number
K023843
Device Name
Endoscopic Tissue Approximation Device
Applicant
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO, CA 92675 US
Other 510(k) Applications for this Company
Contact
JAMES W HART
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
11/18/2002
Decision Date
02/14/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact