Device Classification Name |
Blade, Scalpel
|
510(k) Number |
K852141 |
Device Name |
STERILE SURGICAL BLADES |
Applicant |
MILTEX INSTRUMENT CO. |
6 OHIO DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
KLEIN KRAMER |
Correspondent |
MILTEX INSTRUMENT CO. |
6 OHIO DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
KLEIN KRAMER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 05/16/1985 |
Decision Date | 06/13/1985 |
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
|
|
|