Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K974771 |
Device Name |
STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL |
Applicant |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Applicant Contact |
SALMAAN HAMEED |
Correspondent |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Correspondent Contact |
SALMAAN HAMEED |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/22/1997 |
Decision Date | 05/29/1998 |
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
|