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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 K002871
Device Name MODIFICATION TO YASARGIL ANEURYSM CLIPS
Applicant
AESCULAP, INC.
3773 EXECUTIVE CENTER PKWY.
CENTER VALLEY,  PA  18034
Applicant Contact JOYCE THOMAS
Correspondent
AESCULAP, INC.
3773 EXECUTIVE CENTER PKWY.
CENTER VALLEY,  PA  18034
Correspondent Contact JOYCE THOMAS
Regulation Number882.5200
Classification Product Code
HCH  
Date Received09/14/2000
Decision Date 10/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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