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REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN130046
510(k) Type
Direct
Applicant
SOMNA THERAPEUTICS, LLC
Country
United States
FDA Decision
Deleted
Decision Date
3/6/2015
Days to Decision
477 days

REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN130046
510(k) Type
Direct
Applicant
SOMNA THERAPEUTICS, LLC
Country
United States
FDA Decision
Deleted
Decision Date
3/6/2015
Days to Decision
477 days