Device Classification Name |
Connector, Airway (Extension)
|
510(k) Number |
K954197 |
Device Name |
DISPOSABLE FLEX TUBE |
Applicant |
ENGSTROM MEDICAL |
BOX 20109 |
KARLSBODAVAGEN 18 |
S-161 02 BROMMA,
SE
|
|
Applicant Contact |
WULF TREPTE |
Correspondent |
ENGSTROM MEDICAL |
BOX 20109 |
KARLSBODAVAGEN 18 |
S-161 02 BROMMA,
SE
|
|
Correspondent Contact |
WULF TREPTE |
Regulation Number | 868.5810
|
Classification Product Code |
|
Date Received | 09/06/1995 |
Decision Date | 10/26/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|