COOK CERVICAL RIPENING BALLOON— 510(k) K131206
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K131206 for COOK CERVICAL RIPENING BALLOON, Substantially Equivalent on 2013-09-27. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- Product code
- Code PFJ
- Device class
- Class 2
- Regulation
- 21 CFR 884.4260
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.