Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K925903 |
Device Name |
LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION |
Applicant |
BIRTCHER MEDICAL SYSTEMS, INC. |
50 TECHNOLOGY DR. |
IRVINE,
CA
92718
|
|
Applicant Contact |
EILEEN M ANDERSON |
Correspondent |
BIRTCHER MEDICAL SYSTEMS, INC. |
50 TECHNOLOGY DR. |
IRVINE,
CA
92718
|
|
Correspondent Contact |
EILEEN M ANDERSON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/12/1992 |
Decision Date | 12/30/1992 |
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
|