Device Classification Name |
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
|
510(k) Number |
K983220 |
Device Name |
STRYKER INFRAVISION ESOPHAGEAL KIT |
Applicant |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Applicant Contact |
SEAN CAHILL |
Correspondent |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Correspondent Contact |
SEAN CAHILL |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 09/14/1998 |
Decision Date | 06/04/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|