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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 K153542
Device Name Pelican Sling Retractor
Applicant
Beacon Surgical, Inc.
145 Palisade Street
Dobbs Ferry,  NY  10522
Applicant Contact Allan Alward
Correspondent
Beacon Surgical, Inc.
145 Palisade Street
Dobbs Ferry,  NY  10522
Correspondent Contact Allan Alward
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/11/2015
Decision Date 09/07/2016
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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