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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 K903614
Device Name HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE
Applicant
Harvard Apparatus, Inc.
22 Pleasant St.
South Natick,  MA  01760
Applicant Contact REBECCA BEKAMPIS
Correspondent
Harvard Apparatus, Inc.
22 Pleasant St.
South Natick,  MA  01760
Correspondent Contact REBECCA BEKAMPIS
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/09/1990
Decision Date 12/14/1990
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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