REACTIVE SKIN DECONTAMINATION LOTION
FDA 510(k) clearance K023969 · decided 2003-03-25
Clearance details
- K-number
- K023969
- Device name
- REACTIVE SKIN DECONTAMINATION LOTION
- Applicant
- Dept. of the Army
- Decision
- Substantially Equivalent
- Date received
- 2002-11-29
- Decision date
- 2003-03-25
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- MAC
- Device class
- 1
- Regulation number
- 878.4014
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fort Detrick, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DECONTAMINATING KIT, SKIN: M291 (K894455) | Dept. of the Army | 1989-08-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/ recall (Z-0773-2023) | Emergent Protective Products USA Inc | 2023-01-10 |