Decontaminating Kit, Skin: M291
FDA 510(k) K894455 · Dept. of the Army
510(k) numberK894455
Submission
- Device name
- Decontaminating Kit, Skin: M291
- Applicant
- Dept. of the Army
Frederick, MD, US - Received
- July 25, 1989
- Decision date
- August 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MAC – Decontamination Kit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4014
- Specialty
- General, Plastic Surgery
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification…
Other 510(k)s with product code MAC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023969 | Reactive Skin Decontamination LotionMAC · Traditional | Dept. of the Army | 03/25/2003SE |
More from Dept. of the Army
| 510(k) | Device | Decision |
|---|---|---|
| K023969 | Reactive Skin Decontamination LotionMAC · Traditional | 03/25/2003SE |
| K934818 | Hand Held Dental X-Ray DeviceIZL · Traditional | 01/24/1994SE |
| K921613 | Sterilizer, Surg Instr/Dressing #6530-01-306-9510FLE · Traditional | 01/29/1993SE |
| K901760 | Litter, Folding Rigid Pole, DecontaminableFPP · Traditional | 07/10/1990SE |
Questions and answers
When was Decontaminating Kit, Skin: M291 cleared by the FDA?
Decontaminating Kit, Skin: M291 (K894455) received a 510(k) decision of Substantially Equivalent on August 15, 1989, 21 days after the submission was received.
What is the product code of K894455?
The FDA product code is MAC – Decontamination Kit, a Class I (low risk) device regulated under 21 CFR 878.4014.