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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, laparoscopic
510(k) Number K970866
Device Name FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
Applicant
GEORGIA BIOMEDICAL, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA J. M NOLTE, PHD.
Correspondent
GEORGIA BIOMEDICAL, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA J. M NOLTE, PHD.
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/10/1997
Decision Date 01/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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