MEROGEL OTOLOGIC PACK— 510(k) K001148
Substantially EquivalentXomed, Inc.
FDA 510(k) clearance K001148 for MEROGEL OTOLOGIC PACK, Substantially Equivalent on 2000-06-03. Applicant: Xomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Xomed, Inc.
- Product code
- Code KHJ
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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