MICROTEK MEDICAL WARMING DRAPE— 510(k) K060200

Name: FDA 510(k) clearance K060200
Creator: U.S. Food and Drug Administration
Published: 2006-05-31

Substantially Equivalent

Microtek Medical, Inc.

FDA 510(k) clearance K060200 for MICROTEK MEDICAL WARMING DRAPE, Substantially Equivalent on 2006-05-31. Applicant: Microtek Medical, Inc.. Device class: 2.

Clearance details

Applicant: Microtek Medical, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2006-01-26
Decision date: 2006-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, MS, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K060200

K-number listed on FDA's recall record

Z-1964-2018 — Maximal Barrier Drape; Product Codes: ASK-00002-1AClass II·Terminated·Arrow International Inc·20180411

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060200.

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