Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K953967
Device Classification Name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
More FDA Info for this Device
510(K) Number
K953967
Device Name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Applicant
ACT MEDICAL, INC.
100 BEAVER ST.
WALTHAM, MA 02154 US
Other 510(k) Applications for this Company
Contact
JENNA ANDELMAN
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/22/1995
Decision Date
01/22/1996
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