IV PREP KIT W/O DRESSING (NON-STERILE)— 510(k) K925018
UnknownCustomed, Inc.
FDA 510(k) clearance K925018 for IV PREP KIT W/O DRESSING (NON-STERILE), Unknown on 1993-08-27. Applicant: Customed, Inc.. Device class: 2.
Clearance details
- Applicant
- Customed, Inc.
- Product code
- Code LRS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Fajardo, PR, US
Recent devices under product code LRS
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- K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
- K962596 — CUSTOMED BLOOD EXTRACTION KIT
Adverse events under product code LRS
product code LRS- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.