CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor— 510(k) K200221
Substantially EquivalentMick Radio-Nuclear Instruments, Inc.
FDA 510(k) clearance K200221 for CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor, Substantially Equivalent on 2020-02-28. Applicant: Mick Radio-Nuclear Instruments, Inc..
Clearance details
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
- Product code
- Code JAQ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mt. Vernon, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.