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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Aneurysm
510(k) Number K003519
Device Name YASARGIL PERMANENT ANEURYSM CLIPS
Applicant
AESCULAP, INC.
944 MARCON BLVD.
ALLENTOWN,  PA  18109
Applicant Contact JOYCE THOMAS
Correspondent
AESCULAP, INC.
944 MARCON BLVD.
ALLENTOWN,  PA  18109
Correspondent Contact JOYCE THOMAS
Regulation Number882.5200
Classification Product Code
HCH  
Date Received11/15/2000
Decision Date 01/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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