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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 K980530
Device Name PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13
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 Received02/11/1998
Decision Date 05/12/1998
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
Predetermined Change
Control Plan Authorized		 No
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