Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K871568 |
Device Name |
PLEURA-GARD ATS |
Applicant |
CONMED CORP. |
310 BROAD ST. |
UTICA,
NY
13501 -1203
|
|
Applicant Contact |
WILLIAM W ABRAHAM |
Correspondent |
CONMED CORP. |
310 BROAD ST. |
UTICA,
NY
13501 -1203
|
|
Correspondent Contact |
WILLIAM W ABRAHAM |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 04/22/1987 |
Decision Date | 06/22/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|