The following data is part of a premarket notification filed by Dept. Of The Army with the FDA for Reactive Skin Decontamination Lotion.
Device ID | K023969 |
510k Number | K023969 |
Device Name: | REACTIVE SKIN DECONTAMINATION LOTION |
Classification | Decontamination Kit |
Applicant | DEPT. OF THE ARMY CHEMICAL-BIOLOGICAL MGT.OFFICE 64 THOMAS JEFFERSON DRIVE Fort Detrick, MD 21702 |
Contact | Ronald E Clawson |
Correspondent | Ronald E Clawson DEPT. OF THE ARMY CHEMICAL-BIOLOGICAL MGT.OFFICE 64 THOMAS JEFFERSON DRIVE Fort Detrick, MD 21702 |
Product Code | MAC |
CFR Regulation Number | 878.4014 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-29 |
Decision Date | 2003-03-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10817129020010 | K023969 | 000 |
20817129020000 | K023969 | 000 |
10817129020089 | K023969 | 000 |