SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

Set, Perfusion, Kidney, Disposable

ORGAN RECOVERY SYSTEMS, INC.

The following data is part of a premarket notification filed by Organ Recovery Systems, Inc. with the FDA for Sps-1tm Static Preservation Solution, Models Sps-1-500 Ml, Sps 1-1l, Sps-1-2l.

Pre-market Notification Details

• Device ID: K091656
• 510k Number: K091656
• Device Name: SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
• Classification: Set, Perfusion, Kidney, Disposable
• Applicant: ORGAN RECOVERY SYSTEMS, INC. 2570 EAST DEVON AVE Des Plaines, IL 60018 -4912
• Contact: Pj Pardo
• Correspondent: Pj Pardo; ORGAN RECOVERY SYSTEMS, INC. 2570 EAST DEVON AVE Des Plaines, IL 60018 -4912
• Product Code: KDL
• CFR Regulation Number: 876.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-06-09
• Decision Date: 2010-03-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10815045020329	K091656	000
10815045020305	K091656	000
10815045020282	K091656	000