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Second Opinion

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210365
510(k) Type
Traditional
Applicant
Pearl Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/4/2022
Days to Decision
389 days
Submission Type
Summary

Second Opinion

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210365
510(k) Type
Traditional
Applicant
Pearl Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/4/2022
Days to Decision
389 days
Submission Type
Summary