Device Classification Name |
laryngoscope, endoscope
|
510(k) Number |
K930496 |
Device Name |
GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS |
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 | 876.1500
|
Classification Product Code |
|
Date Received | 02/01/1993 |
Decision Date | 04/20/1993 |
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
|
|
|