HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)— 510(k) K900376

Name: FDA 510(k) clearance K900376
Creator: U.S. Food and Drug Administration
Published: 1990-04-10

Substantially Equivalent

Pmt Corp.

FDA 510(k) clearance K900376 for HAND SURGERY AND IRRIGATION TRAY (MODEL 3625), Substantially Equivalent on 1990-04-10. Applicant: Pmt Corp.. Device class: 1.

Clearance details

Applicant: Pmt Corp.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1990-01-26
Decision date: 1990-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, MN, US

Download summary PDF View on FDA.gov ↗

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K944025 — SURGICAL INSTRUMENT TRAY1994-11-22
K912106 — ARTHROSCOPY TRAY1991-08-29
K912053 — OPEN HEART TRAY1991-08-26

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K042901 — ENDOMARK STERILE INDIA INK2005-03-16
K033730 — PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES2004-08-03

Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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