Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K143308
Device Classification Name
Culdoscope (And Accessories)
More FDA Info for this Device
510(K) Number
K143308
Device Name
Culdoscope (And Accessories)
Applicant
APPLIED MEDICAL RESOURCES
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
Other 510(k) Applications for this Company
Contact
Frans VandenBroek
Other 510(k) Applications for this Contact
Regulation Number
884.1640
More FDA Info for this Regulation Number
Classification Product Code
HEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2014
Decision Date
10/13/2015
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
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact