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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 K230070
Device Name MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®
Applicant
Promamedical, Inc.
4585 Ponce De Leon Blvd.
Suite 719
Miami,  FL  33146
Applicant Contact Christian Wehrenpfenning
Correspondent
Nilo Medical Consulting Group, LLC
3491 Denny St.
Pittsburg,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/10/2023
Decision Date 10/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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