510(k) K874665

SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY by Precision Dynamics Corp. — Product Code LRP

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