ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890— 510(k) K014002
Substantially EquivalentFortune Medical Instrument Corp.
FDA 510(k) clearance K014002 for ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890, Substantially Equivalent on 2002-03-04. Applicant: Fortune Medical Instrument Corp.. Device class: 2.
Clearance details
- Applicant
- Fortune Medical Instrument Corp.
- 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
- Taipei Hsien, TW
Recent devices under product code KOB
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- K021142 — ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
- K980917 — ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
- K980919 — ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.