Device Classification Name |
catheters, suction, tracheobronchial
|
510(k) Number |
K952396 |
Device Name |
REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION |
Applicant |
CONTOUR FABRICATORS OF FLORIDA, INC. |
3340-D SCHERER DR. |
ST. PETERSBURG,
FL
33716
|
|
Applicant Contact |
SCOTT WILLIAMS |
Correspondent |
CONTOUR FABRICATORS OF FLORIDA, INC. |
3340-D SCHERER DR. |
ST. PETERSBURG,
FL
33716
|
|
Correspondent Contact |
SCOTT WILLIAMS |
Regulation Number | 868.6810
|
Classification Product Code |
|
Date Received | 05/22/1995 |
Decision Date | 08/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|