INSULATOR WIRE GUIDE— 510(k) K972977
Substantially EquivalentCook Urological, Inc.
FDA 510(k) clearance K972977 for INSULATOR WIRE GUIDE, Substantially Equivalent on 1997-10-10. Applicant: Cook Urological, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook Urological, Inc.
- Product code
- Code KNY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Spencer, IN, US
Recent devices under product code KNY
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