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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfectant, Medical Devices
510(k) Number K940383
Device Name LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK
Applicant
NATIONAL LABORATORIES
225 SUMMIT AVE.
MONTVALE,  NJ  07645 -1575
Applicant Contact MICHELE F HERRITY
Correspondent
NATIONAL LABORATORIES
225 SUMMIT AVE.
MONTVALE,  NJ  07645 -1575
Correspondent Contact MICHELE F HERRITY
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received01/26/1994
Decision Date 03/22/1995
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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