Device Classification Name |
apparatus, suction, single patient use, portable, nonpowered
|
510(k) Number |
K933319 |
Device Name |
BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM |
Applicant |
BIRTCHER MEDICAL SYSTEMS, INC. |
41 BROOKS DR. |
BRAINTREE,
MA
02184
|
|
Applicant Contact |
EILEEN M ANDERSON |
Correspondent |
BIRTCHER MEDICAL SYSTEMS, INC. |
41 BROOKS DR. |
BRAINTREE,
MA
02184
|
|
Correspondent Contact |
EILEEN M ANDERSON |
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 07/07/1993 |
Decision Date | 10/27/1993 |
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
|
|
|