Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K914597 |
Device Name |
SURGICAL MICROPOROUS TAPE (MICROCEL) |
Applicant |
INDUSTRIAS TUK, S.A. DE C.V. |
P.O. BOX 1868 |
64000 MONTEREY |
N.L., MEXICO,
MX
|
|
Applicant Contact |
GUILLERMO A DOUNCE |
Correspondent |
INDUSTRIAS TUK, S.A. DE C.V. |
P.O. BOX 1868 |
64000 MONTEREY |
N.L., MEXICO,
MX
|
|
Correspondent Contact |
GUILLERMO A DOUNCE |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 10/16/1991 |
Decision Date | 03/19/1992 |
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
|
|
|