Cleared Traditional

MITRASHEER TRANSPLANT DRESSING

K911649 · Polymint Industrial Co. , Ltd. · General & Plastic Surgery
Aug 1991
Decision
117d
Days
—
Risk

About This 510(k) Submission

K911649 is an FDA 510(k) clearance for the MITRASHEER TRANSPLANT DRESSING, a Dressing, Wound And Burn, Occlusive, submitted by Polymint Industrial Co. , Ltd. (Wheat Ridge, US). The FDA issued a Cleared decision on August 7, 1991, 117 days after receiving the submission on April 12, 1991. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K911649 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1991
Decision Date August 07, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code MGP — Dressing, Wound And Burn, Occlusive
Device Class —

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