Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K954919 |
Device Name |
MEROCEL SOFT WOUND DRESSING |
Applicant |
MEROCEL CORP. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
DAVID TIMLIN |
Correspondent |
MEROCEL CORP. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216
|
|
Correspondent Contact |
DAVID TIMLIN |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 10/26/1995 |
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
|
|
|