ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION— 510(k) K940176
Substantially EquivalentAckrad Laboratories
FDA 510(k) clearance K940176 for ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION, Substantially Equivalent on 1996-04-23. Applicant: Ackrad Laboratories. Device class: 2.
Clearance details
- Applicant
- Ackrad Laboratories
- Product code
- Code MFD
- Device class
- Class 2
- Regulation
- 21 CFR 884.5250
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cranford, NJ, US
Recent devices under product code MFD
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- K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
- K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
- K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
Data sourced from openFDA. This site is unofficial and independent of the FDA.