Device Classification Name |
clamp, vascular
|
510(k) Number |
K131561 |
Device Name |
SAM JUNCTIONAL TOURNIQUET |
Applicant |
SAM MEDICAL PRODUCTS |
27350 SW 95TH AVE STE 3038 |
Wilsonville,
OR
97070
|
|
Applicant Contact |
JACK N MCCUTCHEON |
Correspondent |
SAM MEDICAL PRODUCTS |
27350 SW 95TH AVE STE 3038 |
Wilsonville,
OR
97070
|
|
Correspondent Contact |
JACK N MCCUTCHEON |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 05/30/2013 |
Decision Date | 07/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|