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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Paddie
510(k) Number K062406
Device Name AESCULAP NEURO PATTIES
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact LISA M BOYLE
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact LISA M BOYLE
Regulation Number882.4700
Classification Product Code
HBA  
Date Received08/17/2006
Decision Date 09/15/2006
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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