Device Classification Name |
blade, scalpel
|
510(k) Number |
K863211 |
Device Name |
KEISEI SURGICAL BLADES (STERILE & NON-STERILE) |
Applicant |
KEISEI MEDICAL INDUSTRIAL CO., LTD. |
9 AUTUMN DR. |
BETHEL,
CT
06801
|
|
Applicant Contact |
DEBORAH A KUTER |
Correspondent |
KEISEI MEDICAL INDUSTRIAL CO., LTD. |
9 AUTUMN DR. |
BETHEL,
CT
06801
|
|
Correspondent Contact |
DEBORAH A KUTER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/20/1986 |
Decision Date | 09/02/1986 |
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
|
|
|