Device Classification Name |
tube, tracheostomy (w/wo connector)
|
510(k) Number |
K820099 |
Device Name |
TRACH TAPE |
Applicant |
STAN-PAK ENT. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
STAN-PAK ENT. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 01/13/1982 |
Decision Date | 02/23/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|