Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376
FDA 510(k) K033447 · Mri Devices Corp.
510(k) numberK033447
Submission
- Device name
- Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376
- Applicant
- Mri Devices Corp.
Waukesha, WI, US - Received
- October 29, 2003
- Decision date
- January 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376 cleared by the FDA?
Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376 (K033447) received a 510(k) decision of Substantially Equivalent on January 28, 2004, 91 days after the submission was received.
What is the product code of K033447?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.