FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CORIOGRAPH Pre-Op Planning and Modeling Services
K Number: K242272
·
Decision Nov 15, 2024
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
22
Review Days
106
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Basic Information
- Device Name
- CORIOGRAPH Pre-Op Planning and Modeling Services
- K Number
- K242272
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blue Belt Technologies, Inc.
- Date Received
- August 1, 2024
- Decision Date
- November 15, 2024
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
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