510(k) K983647
K983647 is an FDA 510(k) premarket notification submitted by Sts Biopolymers for the device "ECHO-COAT ULTRASOUND NEEDLES". The FDA issued a decision of Substantially Equivalent on January 20, 1999. The device falls under product code MJG (Device, Percutaneous, Biopsy), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 1999
- Date Received
- October 16, 1998
- 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