INCUBATOR CAPE— 510(k) K040794

Substantially Equivalent

Wrapped IN Comfort

FDA 510(k) clearance K040794 for INCUBATOR CAPE, Substantially Equivalent on 2004-06-10. 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: 2004-03-29
Decision date: 2004-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Lorenzo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MMP

K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN2009-07-31
K043234 — LIGHT DRAPE2005-05-25
K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS2004-11-30
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.