Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K973829 |
Device Name |
IRRIGATION BOTTLE |
Applicant |
AUTOMATIC LIQUID PACKAGING, INC. |
2200 W. LAKE SHORE DR. |
WOODSTOCK,
IL
60098
|
|
Applicant Contact |
JOHN BRDA |
Correspondent |
AUTOMATIC LIQUID PACKAGING, INC. |
2200 W. LAKE SHORE DR. |
WOODSTOCK,
IL
60098
|
|
Correspondent Contact |
JOHN BRDA |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 10/07/1997 |
Decision Date | 02/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|