Device Classification Name |
Tape And Bandage, Adhesive
|
510(k) Number |
K930457 |
Device Name |
MEDIMAC BANDAGE |
Applicant |
ENQUAY PHARMACEUTICAL |
2840 N.W. 2ND AVE. |
SUITE 213 |
BOCA RATON,
FL
33431
|
|
Applicant Contact |
BERNARD KOROL |
Correspondent |
ENQUAY PHARMACEUTICAL |
2840 N.W. 2ND AVE. |
SUITE 213 |
BOCA RATON,
FL
33431
|
|
Correspondent Contact |
BERNARD KOROL |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 01/28/1993 |
Decision Date | 01/25/1994 |
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
|
|
|