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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K110253
FOIA Releasable 510(k) K110253
Device Name REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
Applicant
Dana Products, Inc.
7 Corey Dr.
South Barrington,  IL  60010
Applicant Contact HARRY BALA
Correspondent
Dana Products, Inc.
7 Corey Dr.
South Barrington,  IL  60010
Correspondent Contact HARRY BALA
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received01/28/2011
Decision Date 04/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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