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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 K961044
Device Name NOVIGUARD QUICK DRY
Applicant
Dr. Novis Smith & Co., Inc.
701 Haddon Ave.
Collingswood,  NJ  08108
Applicant Contact NOVIS SMITH
Correspondent
Dr. Novis Smith & Co., Inc.
701 Haddon Ave.
Collingswood,  NJ  08108
Correspondent Contact NOVIS SMITH
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received03/14/1996
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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