Device Classification Name |
Cap, Surgical
|
510(k) Number |
K955833 |
Device Name |
NIOMED SURGICAL CAPS |
Applicant |
AMERASIA CORP. |
4121 TIGRIS WAY |
RIVERSIDE,
CA
92503
|
|
Applicant Contact |
DAVID SONG |
Correspondent |
AMERASIA CORP. |
4121 TIGRIS WAY |
RIVERSIDE,
CA
92503
|
|
Correspondent Contact |
DAVID SONG |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 12/26/1995 |
Decision Date | 03/15/1996 |
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
|
|
|