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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 K123325
Device Name Medafor Direct Gas-Assisted Application System
Applicant
MEDAFOR, INC.
2700 FREEWAY BLVD
SUITE 800
MINNEAPOLIS,  MN  55430
Applicant Contact MELISSA YOUNG
Correspondent
MEDAFOR, INC.
2700 FREEWAY BLVD
SUITE 800
MINNEAPOLIS,  MN  55430
Correspondent Contact MELISSA YOUNG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/26/2012
Decision Date 01/24/2013
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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