INSTACINE— 510(k) K942558
Substantially EquivalentFidelity Medical, Inc.
FDA 510(k) clearance K942558 for INSTACINE, Substantially Equivalent on 1995-05-30. Applicant: Fidelity Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Fidelity Medical, Inc.
- Product code
- Code LMB
- Device class
- Class 1
- Regulation
- 21 CFR 892.2010
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Florham Park, NJ, US
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