AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)— 510(k) K980492
Substantially EquivalentCircon Acmi
FDA 510(k) clearance K980492 for AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F), Substantially Equivalent on 1998-11-17. Applicant: Circon Acmi. Device class: 2.
Clearance details
- Applicant
- Circon Acmi
- Product code
- Code FFK
- Device class
- Class 2
- Regulation
- 21 CFR 876.4480
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code FFK
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