REACTIVE SKIN DECONTAMINATION LOTION— 510(k) K023969

Name: FDA 510(k) clearance K023969
Creator: U.S. Food and Drug Administration
Published: 2003-03-25

Substantially Equivalent

Dept. of the Army

FDA 510(k) clearance K023969 for REACTIVE SKIN DECONTAMINATION LOTION, Substantially Equivalent on 2003-03-25. Applicant: Dept. of the Army. Device class: 1.

Clearance details

Applicant: Dept. of the Army
Product code: Code MAC
Device class: Class 1
Regulation: 21 CFR 878.4014
Advisory panel: General, Plastic Surgery
Date received: 2002-11-29
Decision date: 2003-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Detrick, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAC

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K894455 — DECONTAMINATING KIT, SKIN: M2911989-08-15

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K921613 — STERILIZER, SURG INSTR/DRESSING #6530-01-306-95101993-01-29
K901760 — LITTER, FOLDING RIGID POLE, DECONTAMINABLE1990-07-10

Recalls naming K023969

K-number listed on FDA's recall record

Z-0773-2023 — RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.Class I·Terminated·Emergent Protective Products USA Inc·20221124

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023969.

Data sourced from openFDA. This site is unofficial and independent of the FDA.