Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K910362 |
Device Name |
TRACHEOSTOMY CARE KIT |
Applicant |
MEGADYNE MEDICAL PRODUCTS, INC. |
400 OSER AVE. |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
ELLEN JOY |
Correspondent |
MEGADYNE MEDICAL PRODUCTS, INC. |
400 OSER AVE. |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
ELLEN JOY |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 01/29/1991 |
Decision Date | 04/08/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|