GIFT CATHETER SET/S— 510(k) K983590
Substantially EquivalentCook Ob/Gyn
FDA 510(k) clearance K983590 for GIFT CATHETER SET/S, Substantially Equivalent on 1998-12-21. Applicant: Cook Ob/Gyn. Device class: 2.
Clearance details
- Applicant
- Cook Ob/Gyn
- Product code
- Code MQF
- Device class
- Class 2
- Regulation
- 21 CFR 884.6110
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Spencer, IN, US
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- K002385 — COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
Recalls naming K983590
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983590.
Data sourced from openFDA. This site is unofficial and independent of the FDA.