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Route 92 Medical Full Length 088 Access System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210635
510(k) Type
Special
Applicant
Route 92 Medical Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/27/2021
Days to Decision
146 days
Submission Type
Summary

Route 92 Medical Full Length 088 Access System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210635
510(k) Type
Special
Applicant
Route 92 Medical Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/27/2021
Days to Decision
146 days
Submission Type
Summary