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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K895768
Device Name EXEL SAFELET 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 Number880.5200
Classification Product Code
FOZ  
Date Received09/26/1989
Decision Date 02/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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