Device Classification Name |
Tourniquet, Pneumatic
|
510(k) Number |
K954103 |
Device Name |
TOURNI-COMP |
Applicant |
SCANDINAVIAN MEDICAL JW AB |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
SCANDINAVIAN MEDICAL JW AB |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 878.5910
|
Classification Product Code |
|
Date Received | 08/31/1995 |
Decision Date | 11/01/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|