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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 K852615
Device Name R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE
Applicant
Medical Hospital Equipment
236 Third Ave., Suite A
Chula Vista,  CA  92010
Applicant Contact MARUCA, J
Correspondent
Medical Hospital Equipment
236 Third Ave., Suite A
Chula Vista,  CA  92010
Correspondent Contact MARUCA, J
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/12/1985
Decision Date 03/21/1986
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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