Device Classification Name |
assembly, thigh/knee/shank/ankle/foot, external
|
510(k) Number |
K932184 |
Device Name |
STERILE LEMAITRE GLOW 'N TELL TAPE |
Applicant |
VASCUTECH, INC. |
790 TURNPIKE ST. |
NORTH ANDOVER,
MA
01845
|
|
Applicant Contact |
GEORGE LEMAITRE |
Correspondent |
VASCUTECH, INC. |
790 TURNPIKE ST. |
NORTH ANDOVER,
MA
01845
|
|
Correspondent Contact |
GEORGE LEMAITRE |
Regulation Number | 890.3500
|
Classification Product Code |
|
Date Received | 05/05/1993 |
Decision Date | 07/22/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|