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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 K993625
Device Name INSUFFLATION NEEDLE- 120MM, MODEL 900-200
Applicant
Genicon, LC
573 Waterscape Way
Orlando,  FL  32828
Applicant Contact GARY HABERLAND
Correspondent
Genicon, LC
573 Waterscape Way
Orlando,  FL  32828
Correspondent Contact GARY HABERLAND
Regulation Number884.1730
Classification Product Code
HIF  
Date Received10/26/1999
Decision Date 06/20/2000
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
Predetermined Change
Control Plan Authorized		 No
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