Cleared Traditional

NU-GEL * WOUND DRESSING

K983362 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery
Dec 1998
Decision
83d
Days
Risk

About This 510(k) Submission

K983362 is an FDA 510(k) clearance for the NU-GEL * WOUND DRESSING, a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic, submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on December 16, 1998, 83 days after receiving the submission on September 24, 1998. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K983362 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1998
Decision Date December 16, 1998
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class

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