GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER— 510(k) K990753
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K990753 for GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER, Substantially Equivalent on 1999-05-27. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- Product code
- Code JAQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5700
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.