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GelPOINT Transvaginal Access Platform

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143308
510(k) Type
Traditional
Applicant
APPLIED MEDICAL RESOURCES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/13/2015
Days to Decision
329 days
Submission Type
Summary

GelPOINT Transvaginal Access Platform

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143308
510(k) Type
Traditional
Applicant
APPLIED MEDICAL RESOURCES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/13/2015
Days to Decision
329 days
Submission Type
Summary