Device Classification Name |
bottle, collection, vacuum
|
510(k) Number |
K882223 |
Device Name |
PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST |
Applicant |
DEKNATEL, INC. |
2300 MARCUS AVE. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
BETTY OROFINO |
Correspondent |
DEKNATEL, INC. |
2300 MARCUS AVE. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
BETTY OROFINO |
Regulation Number | 880.6740
|
Classification Product Code |
|
Date Received | 05/26/1988 |
Decision Date | 08/16/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|