Device Classification Name |
indicator, biological sterilization process
|
510(k) Number |
K092944 |
FOIA Releasable 510(k) |
K092944
|
Device Name |
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION |
Applicant |
DANA PRODUCTS, INC. |
7 COREY DR. |
SOUTH BARINGTON,
IL
60010
|
|
Applicant Contact |
HARRY BALA |
Correspondent |
DANA PRODUCTS, INC. |
7 COREY DR. |
SOUTH BARINGTON,
IL
60010
|
|
Correspondent Contact |
HARRY BALA |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 09/24/2009 |
Decision Date | 03/18/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|