Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K983000 |
Device Name |
CRICOTHYROTOMY TUBE |
Applicant |
POLAMEDCO, INC. |
4054 GLENCOE AVE. |
MARINA DEL REY,
CA
90292 -5608
|
|
Applicant Contact |
JERRY W HARRER |
Correspondent |
POLAMEDCO, INC. |
4054 GLENCOE AVE. |
MARINA DEL REY,
CA
90292 -5608
|
|
Correspondent Contact |
JERRY W HARRER |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 08/27/1998 |
Decision Date | 10/27/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|