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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transilluminator, Ac-Powered
510(k) Number K940393
Device Name PEREGRINE WIDE ANGLE LIGHT PIPE
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 Number886.1945
Classification Product Code
HJM  
Date Received01/26/1994
Decision Date 09/02/1994
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
Recalls CDRH Recalls
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