Device Classification Name |
Table, Operating-Room, Ac-Powered
|
510(k) Number |
K961742 |
Device Name |
DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM |
Applicant |
ALM SURGICAL EQUIPMENT, INC. |
1820 NORTH LEMON ST. |
ANAHEIM,
CA
92801 -1009
|
|
Applicant Contact |
SUSAN NIELSEN |
Correspondent |
ALM SURGICAL EQUIPMENT, INC. |
1820 NORTH LEMON ST. |
ANAHEIM,
CA
92801 -1009
|
|
Correspondent Contact |
SUSAN NIELSEN |
Regulation Number | 878.4960
|
Classification Product Code |
|
Date Received | 05/06/1996 |
Decision Date | 07/26/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|