Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K932743 |
Device Name |
MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION |
Applicant |
SCOTT HEALTH CARE |
P.O. BOX 16598 |
FT. WORTH,
TX
76162
|
|
Applicant Contact |
LARRY BOGART |
Correspondent |
SCOTT HEALTH CARE |
P.O. BOX 16598 |
FT. WORTH,
TX
76162
|
|
Correspondent Contact |
LARRY BOGART |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 06/08/1993 |
Decision Date | 09/10/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|