Device Classification Name |
Needle, Catheter
|
510(k) Number |
K923028 |
Device Name |
TURKEL PNEUMOTHORAX KIT |
Applicant |
SYMBIOSIS CORP. |
8600 N.W. 41 ST. |
MIAMI,
FL
33166
|
|
Applicant Contact |
W SMITH |
Correspondent |
SYMBIOSIS CORP. |
8600 N.W. 41 ST. |
MIAMI,
FL
33166
|
|
Correspondent Contact |
W SMITH |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 06/23/1992 |
Decision Date | 08/04/1992 |
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
|
|
|