Cleared Traditional

FOAM WEDGE

K812482 · Maddak, Inc. · General & Plastic Surgery
Sep 1981
Decision
24d
Days
—
Risk

About This 510(k) Submission

K812482 is an FDA 510(k) clearance for the FOAM WEDGE, submitted by Maddak, Inc. (Walker, US). The FDA issued a Cleared decision on September 24, 1981, 24 days after receiving the submission on August 31, 1981. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K812482 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1981
Decision Date September 24, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code LDQ
Device Class —