UROSTAT— 510(k) K854539
Substantially EquivalentUrologics, Inc.
FDA 510(k) clearance K854539 for UROSTAT, Substantially Equivalent on 1986-02-04. Applicant: Urologics, Inc.. Device class: 2.
Clearance details
- Applicant
- Urologics, Inc.
- Product code
- Code KPN
- Device class
- Class 2
- Regulation
- 21 CFR 876.2040
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Albuquerque, NM, US
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