510(k) K874665
K874665 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY". The FDA issued a decision of Substantially Equivalent (with conditions) on January 20, 1988. The device falls under product code LRP (Tray, Surgical), 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
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- January 20, 1988
- Date Received
- November 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type