SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER— 510(k) K891290
Substantially EquivalentCook Ob/Gyn
FDA 510(k) clearance K891290 for SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER, Substantially Equivalent on 1989-05-23. Applicant: Cook Ob/Gyn. Device class: 2.
Clearance details
- Applicant
- Cook Ob/Gyn
- Product code
- Code HES
- Device class
- Class 2
- Regulation
- 21 CFR 884.1300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Spencer, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.