ACMI BIPOLAR HEMOSTATIC ELECTRODE— 510(k) K803214
Substantially EquivalentAmerican Cystocope Makers, Inc.
FDA 510(k) clearance K803214 for ACMI BIPOLAR HEMOSTATIC ELECTRODE, Substantially Equivalent on 1981-01-15. Applicant: American Cystocope Makers, Inc.. Device class: 2.
Clearance details
- Applicant
- American Cystocope Makers, Inc.
- Product code
- Code FEH
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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