Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K920618 |
Device Name |
AUTOTRANSFUSION SUCTION SET |
Applicant |
LIFESTREAM INT'L, INC. |
2828 N.CRESCENT RIVER DR. |
THE WOODLANDS,
TX
77381
|
|
Applicant Contact |
KRISTA OAKES |
Correspondent |
LIFESTREAM INT'L, INC. |
2828 N.CRESCENT RIVER DR. |
THE WOODLANDS,
TX
77381
|
|
Correspondent Contact |
KRISTA OAKES |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 02/11/1992 |
Decision Date | 03/12/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|