The following data is part of a premarket notification filed by Dept. Of The Army with the FDA for Decontaminating Kit, Skin: M291.
| Device ID | K894455 |
| 510k Number | K894455 |
| Device Name: | DECONTAMINATING KIT, SKIN: M291 |
| Classification | Decontamination Kit |
| Applicant | DEPT. OF THE ARMY MATER DEVEL ACTIVITY SGRD-UMP FORT DETRICK Frederick, MD 21701 -5009 |
| Contact | Ronald E Clawson |
| Correspondent | Ronald E Clawson DEPT. OF THE ARMY MATER DEVEL ACTIVITY SGRD-UMP FORT DETRICK Frederick, MD 21701 -5009 |
| Product Code | MAC |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 1989-07-25 |
| Decision Date | 1989-08-15 |