Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K952565 |
Device Name |
LYOFOAM EXTRA |
Applicant |
ACME UNITED CORP. |
75 KINGS HWY. CUT-OFF |
FAIRFIELD,
CT
06430
|
|
Applicant Contact |
THOMAS E FLYNN |
Correspondent |
ACME UNITED CORP. |
75 KINGS HWY. CUT-OFF |
FAIRFIELD,
CT
06430
|
|
Correspondent Contact |
THOMAS E FLYNN |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 06/02/1995 |
Decision Date | 11/14/1995 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|