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

Marker, Radiographic, Implantable

MRI DEVICES CORP.

The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Cliploc Soft Tissue Marker 18g/100mm (4), /130mm (5 1/8), /150mm (6), Models 12370, 12372, 12376.

Pre-market Notification Details

• Device ID: K033447
• 510k Number: K033447
• Device Name: CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
• Classification: Marker, Radiographic, Implantable
• Applicant: MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186
• Contact: Thomas Schubert
• Correspondent: Thomas Schubert; MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186
• Product Code: NEU
• CFR Regulation Number: 878.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-10-29
• Decision Date: 2004-01-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838072817	K033447	000
00884838072800	K033447	000
00884838072794	K033447	000
00884838072664	K033447	000