Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K830511 |
Device Name |
ZANLEX, ZAN-TEX & ZANDEX |
Applicant |
WINN HIRSCH & ASSOC. |
30 SYLVIA ROAD |
PLAINVIEW ,
NY
11803 -
|
|
Applicant Contact |
WIN HIRSCH |
Correspondent |
WINN HIRSCH & ASSOC. |
30 SYLVIA ROAD |
PLAINVIEW ,
NY
11803 -
|
|
Correspondent Contact |
WIN HIRSCH |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 02/17/1983 |
Decision Date | 03/17/1983 |
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
|
|
|