Device Classification Name |
Arthroscope
|
510(k) Number |
K981269 |
Device Name |
UNIVERSAL DRIVE SYSTEM |
Applicant |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Applicant Contact |
CAROL A WEDEMAN |
Correspondent |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Correspondent Contact |
CAROL A WEDEMAN |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 04/07/1998 |
Decision Date | 06/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|