Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K122172
Device Classification Name
Accessories, Cleaning, For Endoscope
More FDA Info for this Device
510(K) Number
K122172
Device Name
Accessories, Cleaning, For Endoscope
Applicant
CUSTOM ULTRASONICS
144 RAILROAD DR.
IVYLAND, PA 18974 US
Other 510(k) Applications for this Company
Contact
FRANK J WEBER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FEB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2012
Decision Date
01/25/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact