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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Sponge, Surgical
510(k) Number K100551
Device Name ORLOCATE SYSTEM MODEL ORL 100
Applicant
Haldor Advanced Technologies, Ltd.
107 Shavey Tzion
Pardes Hanna,  IL 37052
Applicant Contact SARIT GELBART GAL-ROM
Correspondent
Haldor Advanced Technologies, Ltd.
107 Shavey Tzion
Pardes Hanna,  IL 37052
Correspondent Contact SARIT GELBART GAL-ROM
Regulation Number880.2740
Classification Product Code
LWH  
Date Received02/26/2010
Decision Date 08/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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