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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K080809
Device Name IEC MEDSIGHT AND MEDBRIGHT
Applicant
Innovative Endoscopy Components, LLC
731-733 Shotgun Rd.
Ft. Lauderdale,  FL  33326
Applicant Contact GERALD GOIFITZER
Correspondent
Innovative Endoscopy Components, LLC
731-733 Shotgun Rd.
Ft. Lauderdale,  FL  33326
Correspondent Contact GERALD GOIFITZER
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Code
GCT  
Date Received03/21/2008
Decision Date 08/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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