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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 K926039
Device Name GUIDE-TECH ENCAPSULATED GUIDEWIRE
Applicant
Cape Tech Medical Products
23 Davedon Dr.
Falmouth,  MA  02536
Applicant Contact AL BICCUM
Correspondent
Cape Tech Medical Products
23 Davedon Dr.
Falmouth,  MA  02536
Correspondent Contact AL BICCUM
Regulation Number876.5130
Classification Product Code
KNY  
Date Received12/01/1992
Decision Date 08/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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