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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
Recalls CDRH Recalls
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