510(k) K080674
K080674 is an FDA 510(k) premarket notification submitted by PAJUNK GmbH Medizintechnologie for the device "PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 2008. The device falls under product code MJG (Device, Percutaneous, Biopsy), a Class I device regulated under 21 CFR 878.4800. PAJUNK GmbH Medizintechnologie has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2008
- Date Received
- March 10, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Percutaneous, Biopsy
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type