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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K980797
Device Name PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
Applicant
PEREGRINE SURGICAL LTD.
4050 D SKYRON DR.
DOYLESTOWN,  PA  18901
Applicant Contact TODD RICHMOND
Correspondent
PEREGRINE SURGICAL LTD.
4050 D SKYRON DR.
DOYLESTOWN,  PA  18901
Correspondent Contact TODD RICHMOND
Regulation Number876.1500
Classification Product Code
MPA  
Date Received03/02/1998
Decision Date 05/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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