Device Classification Name |
tourniquet, pneumatic
|
510(k) Number |
K933994 |
Device Name |
ARTHREX TOURNIQUET FOR LEG HOLDER |
Applicant |
ARTHREX, INC. |
3050 NORTH HORSESHOE DR. |
SUITE 200 |
NAPLES,
FL
33942
|
|
Applicant Contact |
LEONARD E BALTZ, JR. |
Correspondent |
ARTHREX, INC. |
3050 NORTH HORSESHOE DR. |
SUITE 200 |
NAPLES,
FL
33942
|
|
Correspondent Contact |
LEONARD E BALTZ, JR. |
Regulation Number | 878.5910
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/17/1993 |
Decision Date | 03/23/1994 |
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
|
|
|