ACKRAD ESOPHAGEAL BALLOON CATHETER SET— 510(k) K952542
Substantially EquivalentAckrad Laboratories
FDA 510(k) clearance K952542 for ACKRAD ESOPHAGEAL BALLOON CATHETER SET, Substantially Equivalent on 1996-04-23. Applicant: Ackrad Laboratories. Device class: 2.
Clearance details
- Applicant
- Ackrad Laboratories
- Product code
- Code BZC
- Device class
- Class 2
- Regulation
- 21 CFR 868.1880
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cranford, NJ, US
Recent devices under product code BZC
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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.