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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coagulator-cutter, endoscopic, unipolar (and accessories)
510(k) Number K010752
Device Name AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact LESLIE YOUNG
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact LESLIE YOUNG
Regulation Number884.4160
Classification Product Code
KNF  
Date Received03/13/2001
Decision Date 06/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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