Device Classification Name |
apparatus, electrosurgical
|
510(k) Number |
K863091 |
Device Name |
BICORD BY QMED |
Applicant |
QMED, INC. |
3001 W. KENTUCKY ST. |
LOUISVILLE,
KY
40211
|
|
Applicant Contact |
LARRY D POTTS |
Correspondent |
QMED, INC. |
3001 W. KENTUCKY ST. |
LOUISVILLE,
KY
40211
|
|
Correspondent Contact |
LARRY D POTTS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/13/1986 |
Decision Date | 08/29/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|