Last synced on 10 January 2025 at 11:05 pm

CoolSeal Reveal

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203640
510(k) Type
Traditional
Applicant
Bolder Surgical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/6/2021
Days to Decision
143 days
Submission Type
Summary

CoolSeal Reveal

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203640
510(k) Type
Traditional
Applicant
Bolder Surgical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/6/2021
Days to Decision
143 days
Submission Type
Summary