Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K984528 |
Device Name |
PARKER FLEX-TIP TRACHEAL TUBE |
Applicant |
PARKER MEDICAL ASSOC. |
109 INVERNESS DRIVE EAST, |
SUITE J |
ENGLEWOOD,
CO
80112 -5105
|
|
Applicant Contact |
JEFFREY D PARKER |
Correspondent |
PARKER MEDICAL ASSOC. |
109 INVERNESS DRIVE EAST, |
SUITE J |
ENGLEWOOD,
CO
80112 -5105
|
|
Correspondent Contact |
JEFFREY D PARKER |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 12/21/1998 |
Decision Date | 07/15/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|