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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Vacuum
510(k) Number K760316
Device Name REGULATORS, LOW SUCTION
Applicant
HARRIS-LAKE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HARRIS-LAKE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6740
Classification Product Code
KDP  
Date Received07/26/1976
Decision Date 08/04/1976
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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