Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K902307 |
Device Name |
SHAW II HEMOSTATIC SURGERY SYSTEM |
Applicant |
HEMOSTATIC SURGERY CORP. |
FOUR EMBARCADERO CENTER, STE |
3320 |
SAN FRANCISCO,
CA
94111
|
|
Applicant Contact |
PHILIP E EGGERS |
Correspondent |
HEMOSTATIC SURGERY CORP. |
FOUR EMBARCADERO CENTER, STE |
3320 |
SAN FRANCISCO,
CA
94111
|
|
Correspondent Contact |
PHILIP E EGGERS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/22/1990 |
Decision Date | 08/17/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|