Device Classification Name |
Instrument, Ultrasonic Surgical
|
510(k) Number |
K981262 |
Device Name |
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
Applicant |
VALLEYLAB, INC. |
5920 LONGBOW DR. |
P.O. BOX 9015 |
BOULDER,
CO
80301
|
|
Applicant Contact |
JULIE ROSS |
Correspondent |
VALLEYLAB, INC. |
5920 LONGBOW DR. |
P.O. BOX 9015 |
BOULDER,
CO
80301
|
|
Correspondent Contact |
JULIE ROSS |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/07/1998 |
Decision Date | 07/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|