T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP— 510(k) K073675

Name: FDA 510(k) clearance K073675
Creator: U.S. Food and Drug Administration
Published: 2008-05-08

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K073675 for T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP, Substantially Equivalent on 2008-05-08. Applicant: Gaymar Industries, Inc.. Device class: 2.

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 2007-12-28
Decision date: 2008-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K073675

K-number listed on FDA's recall record

Z-1013-2018 — T/Pump temperature therapy pump, Models TP700 and TP700CClass III·Terminated·Stryker Medical Division of Stryker Corporation·20171107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073675.

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