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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
510(k) Number K903963
Device Name KITS AND TRAYS FOR ONE TIME USE ONLY
Applicant
Apk Technology
Pob 6462
Ganei Yehuda
Israel,  IL 56905
Applicant Contact AMIR PORAT
Correspondent
Apk Technology
Pob 6462
Ganei Yehuda
Israel,  IL 56905
Correspondent Contact AMIR PORAT
Regulation Number878.4800
Classification Product Code
LRP  
Date Received08/28/1990
Decision Date 07/29/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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