Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K922749 |
Device Name |
LOW PROFILE TRACHEOSTOMY TUBE |
Applicant |
CONCORD/PORTEX |
15 KITT ST. |
KEENE,
NH
03431
|
|
Applicant Contact |
ROBERT WHEELER |
Correspondent |
CONCORD/PORTEX |
15 KITT ST. |
KEENE,
NH
03431
|
|
Correspondent Contact |
ROBERT WHEELER |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 06/08/1992 |
Decision Date | 09/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|