510(k) K023969
- Device
- REACTIVE SKIN DECONTAMINATION LOTION
- Applicant
- DEPT. OF THE ARMY
- 510(k) number
- K023969
- Product code
- MAC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-03-25
- Date received
- 2002-11-29
- Regulation
- 878.4014
- Classification name
- Decontamination Kit
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD E CLAWSON
- Address
- Chemical-Biological Mgt.Office 64 Thomas Jefferson Dr. Fort Detrick MD US 21702 21702
FDA Registration Numbers#
- 1419181
- 1061124
- 3009169861
- 3015173212
- 3004111573
- 1030451
- 1423395
- 1643817
- 3035642068
- 3007329020
- 1423537
- 3009888344
- 3005595283
- 9616088
- 3004519921
- 1422634
Source Documents#
Other 510(k) Records For Product Code MAC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894455 | DECONTAMINATING KIT, SKIN: M291 | Dept. of the Army | 1989-08-15 |
Legacy Summary#
summary
FDA Review#
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