One-Step Suprapubic Introducer— 510(k) K182709
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K182709 for One-Step Suprapubic Introducer, Substantially Equivalent on 2018-12-26. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- Product code
- Code KOB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5090
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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More clearances from Cook Incorporated
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