Device Classification Name |
cuff, tracheal tube, inflatable
|
510(k) Number |
K881514 |
Device Name |
PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM |
Applicant |
HALL LABORATORIES, INC. |
5751 RICHARDS CIRCLE |
SHAWNEE,
KS
66216
|
|
Applicant Contact |
JOHN E HALL |
Correspondent |
HALL LABORATORIES, INC. |
5751 RICHARDS CIRCLE |
SHAWNEE,
KS
66216
|
|
Correspondent Contact |
JOHN E HALL |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 04/11/1988 |
Decision Date | 06/16/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|