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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K170683
Device Name Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
Applicant
Aesculap, Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact Jessica Stigliano
Correspondent
Aesculap, Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact Jessica Stigliano
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
KNS  
Date Received03/07/2017
Decision Date 02/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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