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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837573
Device Name SHARPLAN LASER POSITIONING SYSTEM
Applicant
Laser Industries , Ltd.
Science Based Industrial Park
Atidim Neve Sharett Pob 13135
Tel Aviv,  IL 61131
Correspondent
Laser Industries , Ltd.
Science Based Industrial Park
Atidim Neve Sharett Pob 13135
Tel Aviv,  IL 61131
Date Received05/27/1983
Decision Date 06/28/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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