FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633— 510(k) K974647

Name: FDA 510(k) clearance K974647
Creator: U.S. Food and Drug Administration
Published: 1998-01-05

Substantially Equivalent

Customed, Inc.

FDA 510(k) clearance K974647 for FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633, Substantially Equivalent on 1998-01-05. Applicant: Customed, Inc.. Device class: 2.

Clearance details

Applicant: Customed, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1997-12-12
Decision date: 1998-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fajardo, PR, US

Download summary PDF View on FDA.gov ↗

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