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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K032127
Device Name HEMEDEX FIXATION DEVICE
Applicant
Hemedex Incorporated
7 Tiffany Trl.
Hopkonton,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Hemedex Incorporated
7 Tiffany Trl.
Hopkonton,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number876.5130
Classification Product Code
KNY  
Subsequent Product Codes
DPT   DPW   FGE  
Date Received07/10/2003
Decision Date 12/30/2003
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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