Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K963765 |
Device Name |
STRYKER STRYKEFLOW ELECTROCAUTERY PROBES |
Applicant |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Applicant Contact |
TOM KEAST |
Correspondent |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Correspondent Contact |
TOM KEAST |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/19/1996 |
Decision Date | 01/31/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|