Device Classification Name |
washer, bolt nut
|
510(k) Number |
K130986 |
Device Name |
FRAG-LOC SYSTEM |
Applicant |
ACUMED LLC |
5885 NW CORNELIUS PASS RD. |
HILLSBORO,
OR
97124 -9432
|
|
Applicant Contact |
KARA BUDOR |
Correspondent |
ACUMED LLC |
5885 NW CORNELIUS PASS RD. |
HILLSBORO,
OR
97124 -9432
|
|
Correspondent Contact |
KARA BUDOR |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/09/2013 |
Decision Date | 07/23/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|