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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K861153
Device Name DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES
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 Number880.5860
Classification Product Code
FMF  
Date Received03/26/1986
Decision Date 04/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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