Last synced on 30 September 2022 at 11:05 pm

Regenomer® Syringe, Regenomer® Plug, Regenomer® Block

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150079
510(k) Type
Abbreviated
Applicant
NIBEC CO, LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/10/2015
Days to Decision
329 days
Submission Type
Summary

Regenomer® Syringe, Regenomer® Plug, Regenomer® Block

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150079
510(k) Type
Abbreviated
Applicant
NIBEC CO, LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/10/2015
Days to Decision
329 days
Submission Type
Summary