Device Classification Name |
Staple, Implantable
|
510(k) Number |
K014286 |
Device Name |
SALUTE, MODEL 3022 |
Applicant |
ONUX MEDICAL, INC. |
5 MERRILL DR. |
HAMPTON,
NH
03842
|
|
Applicant Contact |
RUTHANN DEPIETRO |
Correspondent |
ONUX MEDICAL, INC. |
5 MERRILL DR. |
HAMPTON,
NH
03842
|
|
Correspondent Contact |
RUTHANN DEPIETRO |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 12/27/2001 |
Decision Date | 03/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|