510(k) K830235
K830235 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "FRANZEN NEEDLE GUIDE". The FDA issued a decision of Substantially Equivalent on February 23, 1983. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Precision Dynamics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1983
- Date Received
- January 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Aspiration And Injection, Reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type