Device Classification Name |
sterilizer, ethylene-oxide gas
|
510(k) Number |
K014013 |
Device Name |
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM |
Applicant |
H & W TECHNOLOGY, LLC |
P.O. BOX 20281 |
ROCHESTER,
NY
14602 -0281
|
|
Applicant Contact |
CHARLES O HANCOCK |
Correspondent |
H & W TECHNOLOGY, LLC |
P.O. BOX 20281 |
ROCHESTER,
NY
14602 -0281
|
|
Correspondent Contact |
CHARLES O HANCOCK |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 12/05/2001 |
Decision Date | 06/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|