XOMED-TREACE ALPHASCOPE— 510(k) K923830
Substantially EquivalentXomed-Treace, Inc.
FDA 510(k) clearance K923830 for XOMED-TREACE ALPHASCOPE, Substantially Equivalent on 1992-11-09. Applicant: Xomed-Treace, Inc.. Device class: 1.
Clearance details
- Applicant
- Xomed-Treace, Inc.
- Product code
- Code ERA
- Device class
- Class 1
- Regulation
- 21 CFR 874.4770
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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