Cleared Traditional

PRE-ROLLED TUBULAR STOCKINETTE

K831936 · Ormed Mfg., Inc. · General & Plastic Surgery
Dec 1983
Decision
198d
Days
Risk

About This 510(k) Submission

K831936 is an FDA 510(k) clearance for the PRE-ROLLED TUBULAR STOCKINETTE, submitted by Ormed Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1983, 198 days after receiving the submission on June 15, 1983. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K831936 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1983
Decision Date December 30, 1983
Days to Decision 198 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class