COMFIT— 510(k) K834089
Substantially EquivalentAckrad Laboratories
FDA 510(k) clearance K834089 for COMFIT, Substantially Equivalent on 1983-12-29. Applicant: Ackrad Laboratories. Device class: 1.
Clearance details
- Applicant
- Ackrad Laboratories
- Product code
- Code JAY
- Device class
- Class 1
- Regulation
- 21 CFR 868.5280
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code JAY
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- K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
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Data sourced from openFDA. This site is unofficial and independent of the FDA.