Device Classification Name |
Device, Fixation, Tracheal Tube
|
510(k) Number |
K964399 |
Device Name |
DALE ENDOTRACHEAL TUBE HOLDER 270/280 |
Applicant |
DALE MEDICAL PRODUCTS, INC. |
7 CROSS ST. |
P.O. BOX 1556 |
PLAINVILLE,
MA
02762
|
|
Applicant Contact |
SHARON M STEEVES |
Correspondent |
DALE MEDICAL PRODUCTS, INC. |
7 CROSS ST. |
P.O. BOX 1556 |
PLAINVILLE,
MA
02762
|
|
Correspondent Contact |
SHARON M STEEVES |
Regulation Number | 868.5770
|
Classification Product Code |
|
Date Received | 11/04/1996 |
Decision Date | 01/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|