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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refrigerator, Freezer, Blood Storage
510(k) Number K884436
Device Name MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85
Applicant
Harris Mfg. Co.
P.O. Box 5878
Trenton,  NJ  08638
Applicant Contact HARRIS
Correspondent
Harris Mfg. Co.
P.O. Box 5878
Trenton,  NJ  08638
Correspondent Contact HARRIS
Regulation Number864.9700
Classification Product Code
KSE  
Date Received10/21/1988
Decision Date 12/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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