Medline ENFit Connectors— 510(k) K151628
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K151628 for Medline ENFit Connectors, Substantially Equivalent on 2015-07-24. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code PIO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
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Recalls naming K151628
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151628.
Data sourced from openFDA. This site is unofficial and independent of the FDA.