Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K982660 |
Device Name |
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM |
Applicant |
TRANSFUSION TECHNOLOGIES CORP. |
9 ERIE DR. |
NATICK,
MA
01760
|
|
Applicant Contact |
JOHN J SOKOLOWSKI |
Correspondent |
TRANSFUSION TECHNOLOGIES CORP. |
9 ERIE DR. |
NATICK,
MA
01760
|
|
Correspondent Contact |
JOHN J SOKOLOWSKI |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 07/30/1998 |
Decision Date | 03/30/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|