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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K003608
Device Name SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
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 Number884.4120
Classification Product Code
HGI  
Date Received11/22/2000
Decision Date 02/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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