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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 K030174
Device Name GENICON LAPAROSCOPES
Applicant
Genicon, LC
P.O. Box 780038
Orlando,  FL  32878
Applicant Contact GARY HABERLAND
Correspondent
Genicon, LC
P.O. Box 780038
Orlando,  FL  32878
Correspondent Contact GARY HABERLAND
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/17/2003
Decision Date 06/19/2003
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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