Cleared Traditional

K782120 - SPONGE SYSTEM, ROSERING CONTAIN-COUNT (FDA 510(k) Clearance)

Dec 1978
Decision
Days
Risk

K782120 is an FDA 510(k) clearance for the SPONGE SYSTEM, ROSERING CONTAIN-COUNT..

Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1978.

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

Submission Details

510(k) Number K782120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received December 27, 1978
Decision Date December 27, 1978
Days to Decision
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class