Cleared Traditional

K973763 - KENDALL CURITY IODOFORM PACKING STRIP
(FDA 510(k) Clearance)

Dec 1997
Decision
90d
Days
Risk

K973763 is an FDA 510(k) clearance for the KENDALL CURITY IODOFORM PACKING STRIP. This device is classified as a Gauze/sponge, Internal.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on December 31, 1997, 90 days after receiving the submission on October 2, 1997.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K973763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1997
Decision Date December 31, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code EFQ — Gauze/sponge, Internal
Device Class

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