Device Classification Name |
Needle, Suturing, Disposable
|
510(k) Number |
K812444 |
Device Name |
RADIATION STERILIZATION FOR NEEDLE CNTR |
Applicant |
DEVON INDUSTRIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DEVON INDUSTRIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4800 |
Classification Product Code |
|
Date Received | 08/28/1981 |
Decision Date | 12/14/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|