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TAMPONADE BALLOON CUFF

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K833859
510(k) Type
Traditional
Applicant
AMERICAN ENDOSCOPY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/1984
Days to Decision
57 days

TAMPONADE BALLOON CUFF

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K833859
510(k) Type
Traditional
Applicant
AMERICAN ENDOSCOPY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/1984
Days to Decision
57 days