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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 K980027
Device Name PEREGRINE SHIELDED DIFFUSION PROBE
Applicant
PEREGRINE SURGICAL LTD.
4050D SKYRON DR.
DOYLESTOWN,  PA  18901
Applicant Contact TODD RICHMOND
Correspondent
PEREGRINE SURGICAL LTD.
4050D SKYRON DR.
DOYLESTOWN,  PA  18901
Correspondent Contact TODD RICHMOND
Regulation Number876.1500
Classification Product Code
MPA  
Date Received01/05/1998
Decision Date 03/31/1998
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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