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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 K950529
Device Name PEREGRINE DIFFUSION LIGHT PIPE
Applicant
PEREGRINE SURGICAL LTD.
22 SHORT RD.LVD WEST
DOYLESTOWN,  PA  18901
Applicant Contact JOHN E RICHMOND
Correspondent
PEREGRINE SURGICAL LTD.
22 SHORT RD.LVD WEST
DOYLESTOWN,  PA  18901
Correspondent Contact JOHN E RICHMOND
Regulation Number886.1945
Classification Product Code
HJM  
Date Received02/07/1995
Decision Date 06/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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