COSTORSOL— 510(k) K073693

Substantially Equivalent

Preservation Solutions, Inc.

FDA 510(k) clearance K073693 for COSTORSOL, Substantially Equivalent on 2008-07-03. Applicant: Preservation Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Preservation Solutions, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2007-12-31
Decision date: 2008-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Preservation Solutions, Inc.

K151728 — CoStorSol plus G2015-09-18
K091245 — COSTORSOL2009-06-17
K083453 — COSTORSOL2009-01-21
K080432 — MAPERSOL2008-08-08
K022826 — CLEAR-IT ANTI-FOG, MODEL PS0032002-10-09

Recalls naming K073693

K-number listed on FDA's recall record

Z-1387-2018 — Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.Class II·Terminated·Preservation Solutions, Inc.·20180226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073693.

Data sourced from openFDA. This site is unofficial and independent of the FDA.