Device Classification Name |
Sterilizer, Ethylene-Oxide Gas
|
510(k) Number |
K931872 |
Device Name |
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER |
Applicant |
AMERICAN STERILIZER CO. |
2424 WEST 23RD ST. |
P.O. BOX 620 |
ERIE,
PA
16514
|
|
Applicant Contact |
MICHAEL J ZMUDA |
Correspondent |
AMERICAN STERILIZER CO. |
2424 WEST 23RD ST. |
P.O. BOX 620 |
ERIE,
PA
16514
|
|
Correspondent Contact |
MICHAEL J ZMUDA |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 04/14/1993 |
Decision Date | 02/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|