UROTRACT I— 510(k) K955019
Substantially EquivalentDornier Medtech America, Inc.
FDA 510(k) clearance K955019 for UROTRACT I, Substantially Equivalent on 1995-12-06. Applicant: Dornier Medtech America, Inc.. Device class: 1.
Clearance details
- Applicant
- Dornier Medtech America, Inc.
- Product code
- Code KQS
- Device class
- Class 1
- Regulation
- 21 CFR 876.4890
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kennesaw, GA, US
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