Device Classification Name |
motor, surgical instrument, ac-powered
|
510(k) Number |
K050519 |
Device Name |
ADVANCED TURBO DRIVE SYSTEM |
Applicant |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Applicant Contact |
ELIZABETH PAUL |
Correspondent |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Correspondent Contact |
ELIZABETH PAUL |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 03/01/2005 |
Decision Date | 05/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|