Device Classification Name |
Endoscope, Flexible
|
510(k) Number |
K920979 |
Device Name |
CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) |
Applicant |
Codman & Shurtleff, Inc. |
C/O MEDICAL DEVICE CONSULTANTS |
45 WEST STREET, SUITE 2 |
ATTLEBORO,
MA
02703
|
|
Applicant Contact |
JAMES R VEALE |
Correspondent |
Codman & Shurtleff, Inc. |
C/O MEDICAL DEVICE CONSULTANTS |
45 WEST STREET, SUITE 2 |
ATTLEBORO,
MA
02703
|
|
Correspondent Contact |
JAMES R VEALE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/02/1992 |
Decision Date | 03/23/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|