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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 K123728
Device Name RETRIEVAL BAG
Applicant
FLEXBAR MACHINE CORP.
30 NORTHPORT ROAD
SOUND BEACH,  NY  11789
Applicant Contact STEPHEN T MLCOCH
Correspondent
FLEXBAR MACHINE CORP.
30 NORTHPORT ROAD
SOUND BEACH,  NY  11789
Correspondent Contact STEPHEN T MLCOCH
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/04/2012
Decision Date 12/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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