FLEXISCOPE, MODELS 50MH AND 50 MHC— 510(k) K053412
Substantially EquivalentSchoelly Imaging, Inc.
FDA 510(k) clearance K053412 for FLEXISCOPE, MODELS 50MH AND 50 MHC, Substantially Equivalent on 2006-02-23. Applicant: Schoelly Imaging, Inc.. Device class: 1.
Clearance details
- Applicant
- Schoelly Imaging, Inc.
- Product code
- Code FWF
- Device class
- Class 1
- Regulation
- 21 CFR 878.4160
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ayer, MA, US
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