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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 K940392
Device Name PEREGRINE PIC MINIPULATOR
Applicant
Peregrine Surgical , Ltd.
73 Old Dublin Pike
Doylestown,  PA  18901
Applicant Contact JOHN E RICHMOND
Correspondent
Peregrine Surgical , Ltd.
73 Old Dublin Pike
Doylestown,  PA  18901
Correspondent Contact JOHN E RICHMOND
Regulation Number886.4360
Classification Product Code
KYG  
Date Received01/26/1994
Decision Date 08/23/1994
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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