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MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

Page Type
Cleared 510(K)
510(k) Number
K233185
510(k) Type
Special
Applicant
C2DX, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/24/2023
Days to Decision
26 days
Submission Type
Summary

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

Page Type
Cleared 510(K)
510(k) Number
K233185
510(k) Type
Special
Applicant
C2DX, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/24/2023
Days to Decision
26 days
Submission Type
Summary