ENDOSOPIC STENE MANIPULATING BALLOON— 510(k) K850489
Substantially EquivalentMill-Rose Laboratory
FDA 510(k) clearance K850489 for ENDOSOPIC STENE MANIPULATING BALLOON, Substantially Equivalent on 1985-04-22. Applicant: Mill-Rose Laboratory. Device class: 2.
Clearance details
- Applicant
- Mill-Rose Laboratory
- Product code
- Code LQR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Recent devices under product code LQR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.