CYSTOTOMES/KNIFES— 510(k) K880345
Substantially EquivalentMyocure, Inc.
FDA 510(k) clearance K880345 for CYSTOTOMES/KNIFES, Substantially Equivalent on 1988-05-03. Applicant: Myocure, Inc.. Device class: 1.
Clearance details
- Applicant
- Myocure, Inc.
- Product code
- Code HNY
- Device class
- Class 1
- Regulation
- 21 CFR 886.4350
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Glendale, CA, US
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