Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K993045 |
Device Name |
BARIATRIC LAPAROSCOPE, MODEL 367 |
Applicant |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Applicant Contact |
ROBERT H DAHLA |
Correspondent |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Correspondent Contact |
ROBERT H DAHLA |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/10/1999 |
Decision Date | 10/27/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|