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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K945481
Device Name SHAVE PREP KIT
Applicant
Harding Industries, Inc.
35 Abbett Ave.
P.O. Box 2119
Morristown,  NJ  07962
Applicant Contact MATTHEW GOODWIN
Correspondent
Harding Industries, Inc.
35 Abbett Ave.
P.O. Box 2119
Morristown,  NJ  07962
Correspondent Contact MATTHEW GOODWIN
Regulation Number878.4370
Classification Product Code
LRO  
Date Received11/08/1994
Decision Date 12/23/1994
Decision Substantially Equivalent - Kit (SESK)
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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