Cleared Traditional

CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING

K945977 · Tri-State Hospital Supply Corp. · General & Plastic Surgery
Mar 1995
Decision
111d
Days
Risk

About This 510(k) Submission

K945977 is an FDA 510(k) clearance for the CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING, a Dressing, Wound And Burn, Occlusive, submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on March 29, 1995, 111 days after receiving the submission on December 8, 1994. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K945977 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1994
Decision Date March 29, 1995
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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

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