Device Classification Name |
single-use reprocessed ultrasonic surgical instruments
|
510(k) Number |
K043315 |
Device Name |
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL |
Applicant |
VANGUARD MEDICAL CONCEPTS, INC. |
5307 GREAT OAK DR. |
LAKELAND,
FL
33815
|
|
Applicant Contact |
HEATHER CRAWFORD |
Correspondent |
VANGUARD MEDICAL CONCEPTS, INC. |
5307 GREAT OAK DR. |
LAKELAND,
FL
33815
|
|
Correspondent Contact |
HEATHER CRAWFORD |
Classification Product Code |
|
Date Received | 12/01/2004 |
Decision Date | 03/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|