Device Classification Name |
bottle, collection, vacuum
|
510(k) Number |
K896697 |
Device Name |
PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI |
Applicant |
DEKNATEL, INC. |
KILOMETER 9 CARRETERA |
SAN JOSE-HEREDIA,
CR
|
|
Applicant Contact |
HARRY SAVARD |
Correspondent |
DEKNATEL, INC. |
KILOMETER 9 CARRETERA |
SAN JOSE-HEREDIA,
CR
|
|
Correspondent Contact |
HARRY SAVARD |
Regulation Number | 880.6740
|
Classification Product Code |
|
Date Received | 11/28/1989 |
Decision Date | 02/08/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|