Device Classification Name |
arthroscope
|
510(k) Number |
K941691 |
FOIA Releasable 510(k) |
K941691
|
Device Name |
REVO ROTATOR CUFF REPAIR SYSTEM |
Applicant |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773
|
|
Applicant Contact |
CAROLE A WEIDEMAN |
Correspondent |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773
|
|
Correspondent Contact |
CAROLE A WEIDEMAN |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 04/06/1994 |
Decision Date | 09/06/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|