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PIXEL 3 SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN130015
510(k) Type
Direct
Applicant
GAUSS SURGICAL, INC.
Country
United States
FDA Decision
Deleted
Decision Date
5/9/2014
Days to Decision
459 days

PIXEL 3 SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN130015
510(k) Type
Direct
Applicant
GAUSS SURGICAL, INC.
Country
United States
FDA Decision
Deleted
Decision Date
5/9/2014
Days to Decision
459 days