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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trephine, Manual, Ophthalmic
510(k) Number K862524
Device Name DEKNATEL (R) TREPHINE
Applicant
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Applicant Contact OROFINO
Correspondent
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Correspondent Contact OROFINO
Regulation Number886.4350
Classification Product Code
HRH  
Date Received07/02/1986
Decision Date 08/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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