Device Classification Name |
Forceps, Biopsy, Non-Electric, Reprocessed
|
510(k) Number |
K042594 |
Device Name |
VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS |
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 | 876.1075
|
Classification Product Code |
|
Date Received | 09/23/2004 |
Decision Date | 01/25/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|