Device Classification Name |
Blade, Scalpel
|
510(k) Number |
K854860 |
Device Name |
BLADES, SCALPEL CARBON STEET |
Applicant |
MEDELEC INTL. CORP. |
ONE LINCOLN ROAD, SUITE 304 |
MIAMI BEACH,
FL
33139
|
|
Applicant Contact |
OSCAR D DOCAL |
Correspondent |
MEDELEC INTL. CORP. |
ONE LINCOLN ROAD, SUITE 304 |
MIAMI BEACH,
FL
33139
|
|
Correspondent Contact |
OSCAR D DOCAL |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 12/05/1985 |
Decision Date | 12/24/1985 |
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
|
|
|