Cleared Traditional

K802976 - CARBONACRYL
(FDA 510(k) Clearance)

Dec 1980
Decision
28d
Days
Risk

K802976 is an FDA 510(k) clearance for the CARBONACRYL..

Submitted by Ipos Luneburg (Mchenry, US). The FDA issued a Cleared decision on December 19, 1980, 28 days after receiving the submission on November 21, 1980.

This device falls under the Physical Medicine FDA review panel.

Submission Details

510(k) Number K802976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1980
Decision Date December 19, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code
Device Class