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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 K030429
Device Name STERRAD 200 STERILIZER
Original Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine,  CA  92618
Original Contact natalie bennington
Regulation Number880.6860
Classification Product Code
MLR  
Subsequent Product Code
FLF  
Date Received02/10/2003
Decision Date 08/18/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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