Cleared Traditional

K811279 - AFTERLOADING CATHETER SET (FDA 510(k) Clearance)

Aug 1981
Decision
102d
Days
Risk

K811279 is an FDA 510(k) clearance for the AFTERLOADING CATHETER SET..

Submitted by Mick Radio-Nuclear Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 18, 1981, 102 days after receiving the submission on May 8, 1981.

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

Submission Details

510(k) Number K811279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1981
Decision Date August 18, 1981
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class