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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 K920205
Device Name OTT INSUFFLATION FILTER TUBING
Applicant
Georgia Biomedical Research Group, Inc.
250 Charter Ln., Suite 101
Macon,  GA  31210
Applicant Contact DOUGLAS E OTT
Correspondent
Georgia Biomedical Research Group, Inc.
250 Charter Ln., Suite 101
Macon,  GA  31210
Correspondent Contact DOUGLAS E OTT
Regulation Number884.1730
Classification Product Code
HIF  
Date Received01/16/1992
Decision Date 10/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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