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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K031023
Device Name PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
Applicant
PEREGRINE SURGICAL LTD.
51 BRITAIN DR.
NEW BRITAIN,  PA  18901
Applicant Contact TODD RICHMOND
Correspondent
PEREGRINE SURGICAL LTD.
51 BRITAIN DR.
NEW BRITAIN,  PA  18901
Correspondent Contact TODD RICHMOND
Regulation Number886.4390
Classification Product Code
HQF  
Date Received03/31/2003
Decision Date 06/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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