Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K935234 |
Device Name |
STRYKER ENDOSCOPIC VIDEO ACCESSORIES |
Applicant |
Stryker Endoscopy |
210 BAYPOINTE PKWY. |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
THOMAS KELLY |
Correspondent |
Stryker Endoscopy |
210 BAYPOINTE PKWY. |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
THOMAS KELLY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/01/1993 |
Decision Date | 03/18/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|