Device Classification Name |
blade, scalpel
|
510(k) Number |
K880244 |
Device Name |
SURGICAL BLADES |
Applicant |
AILEE C/O HAVEL'S, INC. |
3726 LONSDALE AVE. |
CINCINNATI,
OH
45227
|
|
Applicant Contact |
HO LEE |
Correspondent |
AILEE C/O HAVEL'S, INC. |
3726 LONSDALE AVE. |
CINCINNATI,
OH
45227
|
|
Correspondent Contact |
HO LEE |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 01/20/1988 |
Decision Date | 02/10/1988 |
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
|
|
|