Cleared Traditional

KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)

K973507 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery
Dec 1997
Decision
90d
Days
—
Risk

About This 510(k) Submission

K973507 is an FDA 510(k) clearance for the KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317), a Dressing, Wound, Drug, submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on December 15, 1997, 90 days after receiving the submission on September 16, 1997. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K973507 FDA.gov
FDA Decision Cleared SN
Date Received September 16, 1997
Decision Date December 15, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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

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