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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Esophageal
510(k) Number K926038
Device Name FLEX-TECH BALLOON DILATOR
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 Number876.5365
Classification Product Code
KNQ  
Date Received12/01/1992
Decision Date 10/25/1993
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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