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

Set, Administration, Intravascular

REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Repro-med Systems, Inc. Dba Rms Medical Products with the FDA for Model Number: Rms1-2604, Rms1-2614, Rms1-2404, Rms1-2414, Rms2-2604, Rms2-2614, Rms2-2404, Rms2-2414, Rms3-2604, Rms3-26.

Pre-market Notification Details

• Device ID: K122404
• 510k 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
• Classification: Set, Administration, Intravascular
• Applicant: REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS 24 CARPENTER RD Chester, NY 10918
• Contact: Andrew I Sealfon
• Correspondent: Andrew I Sealfon; REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS 24 CARPENTER RD Chester, NY 10918
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-07
• Decision Date: 2013-05-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10659443000237	K122404	000
10659443000350	K122404	000
10659443000367	K122404	000
10659443000374	K122404	000
10659443000381	K122404	000
10659443000398	K122404	000
10659443000404	K122404	000
10659443000411	K122404	000
10659443000428	K122404	000
10659443000435	K122404	000
10659443000343	K122404	000
10659443000336	K122404	000
10659443000244	K122404	000
10659443000251	K122404	000
10659443000268	K122404	000
10659443000275	K122404	000
10659443000282	K122404	000
10659443000299	K122404	000
10659443000305	K122404	000
10659443000312	K122404	000
10659443000329	K122404	000
10659443000442	K122404	000
10659443000459	K122404	000
10659443000466	K122404	000
10659443000589	K122404	000
10659443000596	K122404	000
10659443000602	K122404	000
10659443000619	K122404	000
10659443000626	K122404	000
10659443000633	K122404	000
10659443000640	K122404	000
10659443000657	K122404	000
10659443000664	K122404	000
10659443000572	K122404	000
10659443000565	K122404	000
10659443000473	K122404	000
10659443000480	K122404	000
10659443000497	K122404	000
10659443000503	K122404	000
10659443000510	K122404	000
10659443000527	K122404	000
10659443000534	K122404	000
10659443000541	K122404	000
10659443000558	K122404	000
10659443000671	K122404	000