Device Classification Name |
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
|
510(k) Number |
K043198 |
Device Name |
VANGUARD REPROCESSED ARTHROSCOPIC WANDS |
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 |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/18/2004 |
Decision Date | 05/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|