Device Classification Name |
kit, surgical instrument, disposable
|
510(k) Number |
K925215 |
Device Name |
STERILE SURGICAL INSTRUMENT TRAYS |
Applicant |
AMERICAN HEALTHCARE SUPPLY CO., INC. |
6 INGERSOLL RD. |
P.O. BOX 544 |
SOUTH PLAINFIELD,
NJ
07080
|
|
Applicant Contact |
RALPH S JARRETT |
Correspondent |
AMERICAN HEALTHCARE SUPPLY CO., INC. |
6 INGERSOLL RD. |
P.O. BOX 544 |
SOUTH PLAINFIELD,
NJ
07080
|
|
Correspondent Contact |
RALPH S JARRETT |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 10/16/1992 |
Decision Date | 06/01/1993 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|