Device Classification Name |
prosthesis, nose, internal
|
510(k) Number |
K041690 |
Device Name |
MONARCH NASAL IMPLANT |
Applicant |
HANSON MEDICAL, INC. |
P.O. BOX 1160 |
KINGSTON,
WA
98346
|
|
Applicant Contact |
GERALD HANSON |
Correspondent |
HANSON MEDICAL, INC. |
P.O. BOX 1160 |
KINGSTON,
WA
98346
|
|
Correspondent Contact |
GERALD HANSON |
Regulation Number | 878.3680
|
Classification Product Code |
|
Date Received | 06/22/2004 |
Decision Date | 02/11/2005 |
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
|
|
|