Device Classification Name |
scalpel, one-piece
|
510(k) Number |
K780998 |
Device Name |
SCALPEL |
Applicant |
ISOLAB, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ISOLAB, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 06/14/1978 |
Decision Date | 07/27/1978 |
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
|
|
|