Device Classification Name |
table and attachments, operating-room
|
510(k) Number |
K935441 |
Device Name |
INFINITECH BREATH EZ |
Applicant |
INFINITECH, INC. |
500 SOUTH EWING |
ST. LOUIS,
MO
63103
|
|
Applicant Contact |
ALAN T BECKMAN |
Correspondent |
INFINITECH, INC. |
500 SOUTH EWING |
ST. LOUIS,
MO
63103
|
|
Correspondent Contact |
ALAN T BECKMAN |
Regulation Number | 878.4950
|
Classification Product Code |
|
Date Received | 11/12/1993 |
Decision Date | 02/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|