PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5— 510(k) K092136
Substantially EquivalentIsoray Medical, Inc.
FDA 510(k) clearance K092136 for PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5, Substantially Equivalent on 2009-08-07. 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
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