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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 WEST ST.
SUITE 2
ATTLEBORO,  MA  02703
Applicant Contact WILLIAM A MORTON
Correspondent
STERIS C/O MEDICAL DEVICE CONSULTANTS, INC.
45 WEST ST.
SUITE 2
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
Recalls CDRH Recalls
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