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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Eyepiece, For Insertion Of Prescription Lens
510(k) Number K895772
Device Name EXEL INDWELLING CATHETER
Applicant
Exel Intl.
P.O. Box 3194
Culver City,  CA  90231
Applicant Contact ESHAGH HAMID
Correspondent
Exel Intl.
P.O. Box 3194
Culver City,  CA  90231
Correspondent Contact ESHAGH HAMID
Regulation Number876.1500
Classification Product Code
FDZ  
Date Received09/26/1989
Decision Date 02/16/1990
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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