Device Classification Name |
catheter, cholangiography
|
510(k) Number |
K830711 |
Device Name |
TRACHESTOMY & NASAL SUCTIONING KIT #- |
Applicant |
INTERTEX MEDICAL |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
INTERTEX MEDICAL |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 03/07/1983 |
Decision Date | 05/02/1983 |
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
|