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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 K032198
Device Name AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact MATTHEW M HULL
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact MATTHEW M HULL
Regulation Number882.5200
Classification Product Code
HCH  
Date Received07/18/2003
Decision Date 08/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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