GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)— 510(k) K111059
Substantially EquivalentGyrus Acmi, Inc.
FDA 510(k) clearance K111059 for GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL), Substantially Equivalent on 2011-09-01. Applicant: Gyrus Acmi, Inc.. Device class: 2.
Clearance details
- Applicant
- Gyrus Acmi, Inc.
- Product code
- Code HIN
- Device class
- Class 2
- Regulation
- 21 CFR 884.4150
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southborough, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.