Device Classification Name |
Laryngoscope, Rigid
|
510(k) Number |
K921166 |
Device Name |
AUGUSTINE GUIDE KIT |
Applicant |
AUGUSTINE MEDICAL, INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
SCOTT D AUGUSTINE |
Correspondent |
AUGUSTINE MEDICAL, INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
SCOTT D AUGUSTINE |
Regulation Number | 868.5540
|
Classification Product Code |
|
Date Received | 03/11/1992 |
Decision Date | 04/23/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|