Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K991695 |
Device Name |
DYNAREX NON-WOVEN SPONGE |
Applicant |
DYNAREX CORP. |
ONE INTERNATIONAL BLVD. |
BREWSTER,
NY
10509
|
|
Applicant Contact |
JOHN G MOULDEN |
Correspondent |
DYNAREX CORP. |
ONE INTERNATIONAL BLVD. |
BREWSTER,
NY
10509
|
|
Correspondent Contact |
JOHN G MOULDEN |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 05/18/1999 |
Decision Date | 07/15/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|