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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K924999
Device Name AUTOPOLE REGULATOR SYSTEM
Applicant
Escalon Trek Medical
182 Tamarack Cir.
Skillmanl,  NJ  08558
Applicant Contact RONALD HUENEKE
Correspondent
Escalon Trek Medical
182 Tamarack Cir.
Skillmanl,  NJ  08558
Correspondent Contact RONALD HUENEKE
Regulation Number886.4360
Classification Product Code
KYG  
Date Received10/02/1992
Decision Date 12/24/1992
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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