PBN DRAINAGE CATHETER GUIDEWIRES— 510(k) K991097
Substantially EquivalentMedical Device Technologies, Inc.
FDA 510(k) clearance K991097 for PBN DRAINAGE CATHETER GUIDEWIRES, Substantially Equivalent on 1999-04-23. Applicant: Medical Device Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Device Technologies, 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
- Gainesville, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.