TAUT BALLOON CATHETER, MODEL 50640— 510(k) K011018
Substantially EquivalentTaut, Inc.
FDA 510(k) clearance K011018 for TAUT BALLOON CATHETER, MODEL 50640, Substantially Equivalent on 2001-06-22. Applicant: Taut, Inc.. Device class: 2.
Clearance details
- Applicant
- Taut, Inc.
- Product code
- Code GCA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geneva, IL, US
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view allData sourced from openFDA. This site is unofficial and independent of the FDA.