ECA— 510(k) K811397
Substantially EquivalentGillco, Inc.
FDA 510(k) clearance K811397 for ECA, Substantially Equivalent on 1981-07-02. Applicant: Gillco, Inc.. Device class: 1.
Clearance details
- Applicant
- Gillco, Inc.
- Product code
- Code FOA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6080
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code FOA
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