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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilizer, chemical
510(k) Number K981625
Device Name STERRAD 50 STERILIZER
Applicant
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Applicant Contact KEVIN CORRIGAN
Correspondent
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Correspondent Contact KEVIN CORRIGAN
Regulation Number880.6860
Classification Product Code
MLR  
Date Received05/07/1998
Decision Date 01/11/1999
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
Recalls CDRH Recalls
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