Cleared Traditional

ADHEROL SEPP APPLICATOR

K952007 · Medi-Flex Hospital Products, Inc. · General & Plastic Surgery
Jun 1995
Decision
41d
Days
—
Risk

About This 510(k) Submission

K952007 is an FDA 510(k) clearance for the ADHEROL SEPP APPLICATOR, a Dressing, Wound, Drug, submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on June 8, 1995, 41 days after receiving the submission on April 28, 1995. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K952007 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1995
Decision Date June 08, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class —

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