Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K952524 |
Device Name |
AESCULAP BIOPOLAR COAGULATOR |
Applicant |
AESCULAP, INC. |
1000 GATEWAY BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
MARY ELLEN HOLDEN |
Correspondent |
AESCULAP, INC. |
1000 GATEWAY BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
MARY ELLEN HOLDEN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/01/1995 |
Decision Date | 06/29/1995 |
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
|