Light Drape
FDA 510(k) K043234 · Wrapped IN Comfort
510(k) numberK043234
Submission
- Device name
- Light Drape
- Applicant
- Wrapped IN Comfort
San Lorenzo, CA, US - Received
- November 22, 2004
- Decision date
- May 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MMP – Cover, Barrier, Protective
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code MMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091178 | MTP Disposable Equipment Covers, Karl Storz 15 Touch ScreenMMP · Traditional | Mtp Medical Technical Promotion GmbH | 07/31/2009SE |
| K041501 | Guangzhou Fortunique Drapes, Bags and CoversMMP · Traditional | Guangzhou Fortunique , Ltd. | 11/30/2004SE |
| K040794 | Incubator CapeMMP · Traditional | Wrapped IN Comfort | 06/10/2004SE |
| K032065 | Medline Band Bags and Equipment CoversMMP · Traditional | Medline Industries, Inc. | 09/22/2003SE |
| K023540 | Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09MMP · Traditional | Valumed | 02/04/2003SE |
| K014239 | Medsurg Equipment CoversMMP · Traditional | International Medsurg Connection | 02/19/2002SE |
| K970885 | Ultrasound Systems DrapeMMP · Traditional | Protek Medical Products, Inc. | 09/22/1997SE |
| K962288 | Cover-All, Drape-It-All, Chair Sleve, X-Ray Sleeve, Headrest CoverMMP · Traditional | Pinnacle Products, Inc. | 01/30/1997SE |
| K961699 | Equipment CoversMMP · Traditional | United States Surgical, A Division of Tyco Healthc | 08/23/1996SE |
| K952241 | Protouch OvergloveMMP · Traditional | Cottrell, Ltd. | 08/07/1995SE |
More from Cottrell, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K040794 | Incubator CapeMMP · Traditional | 06/10/2004SE |
Questions and answers
When was Light Drape cleared by the FDA?
Light Drape (K043234) received a 510(k) decision of Substantially Equivalent on May 25, 2005, 184 days after the submission was received.
What is the product code of K043234?
The FDA product code is MMP – Cover, Barrier, Protective, a Class II (moderate risk) device regulated under 21 CFR 878.4370.