Device Classification Name |
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
|
510(k) Number |
K070420 |
FOIA Releasable 510(k) |
K070420
|
Device Name |
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 |
Applicant |
UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
MICHAEL WOLF |
Correspondent |
BSI HEALTHCARE |
KITEMARK COURT, DAVY AVENUE |
KNOWLHILL |
MILTON KEYNES,
GB
MK5 8PP
|
|
Correspondent Contact |
JOHN HOWLETT |
Regulation Number | 876.1500 |
Classification Product Code |
|
Date Received | 02/20/2007 |
Decision Date | 03/19/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|