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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 K080307
Device Name PROCHEM INDICATOR TAPE
Applicant
RAVEN LABORATORIES
8607 PARK DR.
OMAHA,  NE  68127
Applicant Contact WENDY ROYALTY-HANN
Correspondent
RAVEN LABORATORIES
8607 PARK DR.
OMAHA,  NE  68127
Correspondent Contact WENDY ROYALTY-HANN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received02/05/2008
Decision Date 05/01/2008
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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