Device Classification Name |
Strip, Adhesive, Closure, Skin
|
510(k) Number |
K874813 |
Device Name |
OMED WOUND CLOSURE STRIPS |
Applicant |
OXBORO MEDICAL INTL., INC. |
9635 GIRARD AVE SOUTH |
BLOOMINGTON,
MN
55431
|
|
Applicant Contact |
KEVIN P MAXWELL |
Correspondent |
OXBORO MEDICAL INTL., INC. |
9635 GIRARD AVE SOUTH |
BLOOMINGTON,
MN
55431
|
|
Correspondent Contact |
KEVIN P MAXWELL |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 11/24/1987 |
Decision Date | 01/29/1988 |
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
|
Recalls |
CDRH Recalls
|
|
|