PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2— 510(k) K092458
Substantially EquivalentIsoray Medical, Inc.
FDA 510(k) clearance K092458 for PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2, Substantially Equivalent on 2009-08-28. Applicant: Isoray Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Isoray Medical, Inc.
- Product code
- Code KXK
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Richland, WA, US
Recent devices under product code KXK
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