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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical, Instrument
510(k) Number K895527
Device Name THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM
Applicant
Quantitative Technologies, Inc.
P.O. Box 3067
Louisville,  KY  40201
Applicant Contact KELLY J CONRAD
Correspondent
Quantitative Technologies, Inc.
P.O. Box 3067
Louisville,  KY  40201
Correspondent Contact KELLY J CONRAD
Regulation Number878.4800
Classification Product Code
FSM  
Date Received09/12/1989
Decision Date 10/06/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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