BIOPSY NEEDLE GUIDE ATTACHMENT— 510(k) K863797
Substantially EquivalentElscint, Inc.
FDA 510(k) clearance K863797 for BIOPSY NEEDLE GUIDE ATTACHMENT, Substantially Equivalent on 1987-03-27. Applicant: Elscint, Inc.. Device class: 2.
Clearance details
- Applicant
- Elscint, Inc.
- Product code
- Code HGL
- Device class
- Class 2
- Regulation
- 21 CFR 884.2960
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Itasca, IL, US
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