LIGHT DRAPE— 510(k) K043234

Substantially Equivalent

Wrapped IN Comfort

FDA 510(k) clearance K043234 for LIGHT DRAPE, Substantially Equivalent on 2005-05-25. Applicant: Wrapped IN Comfort. Device class: 2.

Clearance details

Applicant: Wrapped IN Comfort
Product code: Code MMP
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2004-11-22
Decision date: 2005-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Lorenzo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MMP

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K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS2004-11-30
K040794 — INCUBATOR CAPE2004-06-10
K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERS2003-09-22
K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP092003-02-04

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