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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 K881478
Device Name MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS
Applicant
Keymed (Medical & Industrial Equipment), Ltd.
Keymed House,Stock Rd.
Southend-On-Sea, Essex Ss2 5qh
Essex,  GB
Applicant Contact ROGER GRAY
Correspondent
Keymed (Medical & Industrial Equipment), Ltd.
Keymed House,Stock Rd.
Southend-On-Sea, Essex Ss2 5qh
Essex,  GB
Correspondent Contact ROGER GRAY
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received04/06/1988
Decision Date 09/14/1988
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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