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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K003965
Device Name MRI SAFE INSTRUMENTS
Applicant
AESCULAP, INC.
944 MARCON BLVD.
ALLENTOWN,  PA  18109
Applicant Contact LISA M MILLINGTON
Correspondent
AESCULAP, INC.
944 MARCON BLVD.
ALLENTOWN,  PA  18109
Correspondent Contact LISA M MILLINGTON
Regulation Number878.4800
Classification Product Code
GEA  
Subsequent Product Code
GEN  
Date Received12/22/2000
Decision Date 03/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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