Last synced on 16 May 2025 at 11:05 pm

MULTIPLE NAME

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123819
510(k) Type
Traditional
Applicant
TOP CALIBRE SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/5/2013
Days to Decision
83 days
Submission Type
Summary

MULTIPLE NAME

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123819
510(k) Type
Traditional
Applicant
TOP CALIBRE SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
3/5/2013
Days to Decision
83 days
Submission Type
Summary