AMT Low-Profile Suprapubic Catheter & Drainage Set— 510(k) K240514
Substantially EquivalentApplied Medical Technology, Inc.
FDA 510(k) clearance K240514 for AMT Low-Profile Suprapubic Catheter & Drainage Set, Substantially Equivalent on 2024-11-01. Applicant: Applied Medical Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Technology, Inc.
- Product code
- Code KOB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5090
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brecksville, OH, US
Recent devices under product code KOB
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