KENDALL HYDROPHILIC POWDER WOUND DRESSING— 510(k) K970266

Name: FDA 510(k) clearance K970266
Creator: U.S. Food and Drug Administration
Published: 1997-04-23

Substantially Equivalent for Some Indications

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K970266 for KENDALL HYDROPHILIC POWDER WOUND DRESSING, Substantially Equivalent for Some Indications on 1997-04-23. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: Unclassified.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 1997-01-23
Decision date: 1997-04-23
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kendall Healthcare Products Co. Div.Of Tyco Health

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K973763 — KENDALL CURITY IODOFORM PACKING STRIP1997-12-31
K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.