IV PREP KIT (NON-STERILE)— 510(k) K925017
Substantially EquivalentCustomed, Inc.
FDA 510(k) clearance K925017 for IV PREP KIT (NON-STERILE), Substantially Equivalent 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
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fajardo, PR, US
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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.