SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)— 510(k) K904797
Substantially EquivalentSurgitek
FDA 510(k) clearance K904797 for SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16), Substantially Equivalent on 1991-03-05. Applicant: Surgitek. Device class: 2.
Clearance details
- Applicant
- Surgitek
- Product code
- Code FBO
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Racine, WI, US
Recent devices under product code FBO
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- K080780 — ANCHORAGE SCOPE, MODEL 000003
More clearances from Surgitek
view allData sourced from openFDA. This site is unofficial and independent of the FDA.