Device Classification Name |
arthroscope
|
510(k) Number |
K940515 |
Device Name |
POLY BLADES |
Applicant |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773
|
|
Applicant Contact |
CAROL A WEIDEMAN, PH.D. |
Correspondent |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773
|
|
Correspondent Contact |
CAROL A WEIDEMAN, PH.D. |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 02/04/1994 |
Decision Date | 05/26/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|