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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K895848
Device Name PRESSURE STEAM STERILIZERS
Applicant
Scientific Device Laboratory, Inc.
508 Zenith Dr.
Glenview,  IL  60025
Applicant Contact LIPTON, PHD
Correspondent
Scientific Device Laboratory, Inc.
508 Zenith Dr.
Glenview,  IL  60025
Correspondent Contact LIPTON, PHD
Regulation Number880.6880
Classification Product Code
FLE  
Date Received10/03/1989
Decision Date 12/11/1989
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
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