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SANDMAN ELITE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153353
510(k) Type
Traditional
Applicant
EMBLA SYSTEMS
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
6/23/2016
Days to Decision
216 days
Submission Type
Summary

SANDMAN ELITE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153353
510(k) Type
Traditional
Applicant
EMBLA SYSTEMS
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
6/23/2016
Days to Decision
216 days
Submission Type
Summary