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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K861560
Device Name MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE
Applicant
Medi Point, Inc.
72 E. Second St.
Mineola,  NY  11501
Applicant Contact PETER GOLLOBIN
Correspondent
Medi Point, Inc.
72 E. Second St.
Mineola,  NY  11501
Correspondent Contact PETER GOLLOBIN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/25/1986
Decision Date 05/12/1986
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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