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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 K062651
Device Name PROCHEM EXT CHEMICAL INTEGRATOR
Applicant
Raven Biological Laboratories, Inc.
8607 Park Dr.
Omaha,  NE  68127
Applicant Contact WENDY ROYALTY-HANN
Correspondent
Raven Biological Laboratories, Inc.
8607 Park Dr.
Omaha,  NE  68127
Correspondent Contact WENDY ROYALTY-HANN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/07/2006
Decision Date 03/15/2007
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
Predetermined Change
Control Plan Authorized		 No
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