MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26


Device Classification Name

set, administration, intravascular

510(k) Number K122404
Device Name MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
Applicant
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
24 carpenter rd
chester, 
NY 
10918

Applicant Contact andrew i sealfon
Correspondent
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
24 carpenter rd
chester, 
NY 
10918

Correspodent Contact andrew i sealfon
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 08/07/2012
Decision Date 05/06/2013
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