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NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122784
510(k) Type
Traditional
Applicant
BIONESS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/27/2012
Days to Decision
107 days
Submission Type
Summary

NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122784
510(k) Type
Traditional
Applicant
BIONESS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/27/2012
Days to Decision
107 days
Submission Type
Summary