DECONTAMINATING KIT, SKIN: M291
FDA 510(k) clearance K894455 · decided 1989-08-15
Clearance details
- K-number
- K894455
- Device name
- DECONTAMINATING KIT, SKIN: M291
- Applicant
- Dept. of the Army
- Decision
- Substantially Equivalent
- Date received
- 1989-07-25
- Decision date
- 1989-08-15
- Days to decision
- 21 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
- Frederick, 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 |
|---|---|---|
| REACTIVE SKIN DECONTAMINATION LOTION (K023969) | Dept. of the Army | 2003-03-25 |
Recalls involving this device
No recalls on record reference this clearance.