Cleared Traditional

K842626 - HIP PROSTHESIS PACK (FDA 510(k) Clearance)

Oct 1984
Decision
110d
Days
Risk

K842626 is an FDA 510(k) clearance for the HIP PROSTHESIS PACK..

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on October 24, 1984, 110 days after receiving the submission on July 6, 1984.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number K842626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1984
Decision Date October 24, 1984
Days to Decision 110 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary

Device Classification

Product Code
Device Class