Device Classification Name |
Washer, Bolt Nut
|
510(k) Number |
K143092 |
Device Name |
Tensyn Plug |
Applicant |
DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G |
San Clemente,
CA
92673
|
|
Applicant Contact |
Al Memmolo |
Correspondent |
DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G |
San Clemente,
CA
92673
|
|
Correspondent Contact |
Al Memmolo |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 10/28/2014 |
Decision Date | 02/11/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|