CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376— 510(k) K033447

Substantially Equivalent

Mri Devices Corp.

FDA 510(k) clearance K033447 for CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376, Substantially Equivalent on 2004-01-28. Applicant: Mri Devices Corp.. Device class: 2.

Clearance details

Applicant
Mri Devices Corp.
Product code
Code NEU
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waukesha, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NEU

product code NEU
Injury
824
Total
824

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

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