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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K875280
Device Name STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT
Applicant
Steris C/O Medical Device Consultants, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact WILLIAM A MORTON
Correspondent
Steris C/O Medical Device Consultants, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact WILLIAM A MORTON
Regulation Number880.6885
Classification Product Code
MED  
Date Received12/24/1987
Decision Date 09/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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