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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K081031
Device Name ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact Lisa Boyle
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact Lisa Boyle
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDO  
Date Received04/11/2008
Decision Date 05/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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