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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 -0038
Applicant Contact GARY HABERLAND
Correspondent
GENICON, LC
P.O. BOX 780038
ORLANDO,  FL  32878 -0038
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
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