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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K053028
Device Name TECHDEVICE GUIDEWIRE
Applicant
TECHDEVICE CORPORATION
650 PLEASANT ST.
WATERTOWN,  MA  02472
Applicant Contact LEIGH HAYWARD
Correspondent
TECHDEVICE CORPORATION
650 PLEASANT ST.
WATERTOWN,  MA  02472
Correspondent Contact LEIGH HAYWARD
Regulation Number876.1500
Classification Product Code
OCY  
Date Received10/27/2005
Decision Date 01/31/2006
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
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