Cleared Traditional

K850152 - PRECONNECTED URETHRAL CATHETER TRAY (FDA 510(k) Clearance)

Mar 1985
Decision
56d
Days
Risk

K850152 is an FDA 510(k) clearance for the PRECONNECTED URETHRAL CATHETER TRAY..

Submitted by Inmed Corp. (Norcross, US). The FDA issued a Cleared decision on March 12, 1985, 56 days after receiving the submission on January 15, 1985.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K850152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1985
Decision Date March 12, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class