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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 K092821
Device Name TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021
Applicant
Agency For Medical Innovations, Inc.
20 Main St., Suite 205
Natick,  MA  01760
Applicant Contact ANDREW BENDHEIM
Correspondent
Agency For Medical Innovations, Inc.
20 Main St., Suite 205
Natick,  MA  01760
Correspondent Contact ANDREW BENDHEIM
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/14/2009
Decision Date 02/01/2010
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
Predetermined Change
Control Plan Authorized		 No
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