Device Classification Name |
instrument, biopsy, mechanical, gastrointestinal
|
510(k) Number |
K984168 |
Device Name |
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE |
Applicant |
UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
DEAN SECREST |
Correspondent |
UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
DEAN SECREST |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 11/20/1998 |
Decision Date | 12/07/1999 |
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
|
|
|