Device Classification Name |
Prosthesis, Nose, Internal
|
510(k) Number |
K961124 |
Device Name |
THE NAUTILUS |
Applicant |
RAND SCIENTIFIC CORP. |
4135 NORTHGATE BLVD., SUITE 9 |
SACRAMENTO,
CA
95834
|
|
Applicant Contact |
DUANE TRACY |
Correspondent |
RAND SCIENTIFIC CORP. |
4135 NORTHGATE BLVD., SUITE 9 |
SACRAMENTO,
CA
95834
|
|
Correspondent Contact |
DUANE TRACY |
Regulation Number | 878.3680
|
Classification Product Code |
|
Date Received | 03/21/1996 |
Decision Date | 04/19/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|