URESIL TRU-CLOSE DRAINAGE BAG— 510(k) K901844
Substantially EquivalentUresil Corp.
FDA 510(k) clearance K901844 for URESIL TRU-CLOSE DRAINAGE BAG, Substantially Equivalent on 1990-06-01. Applicant: Uresil Corp.. Device class: 2.
Clearance details
- Applicant
- Uresil Corp.
- Product code
- Code EXF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skokie, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.