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AIRE-CUF TRACHEOSTOMY TUBE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K812163
510(k) Type
Traditional
Applicant
BIOANA SURGICAL INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/1981
Days to Decision
54 days

AIRE-CUF TRACHEOSTOMY TUBE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K812163
510(k) Type
Traditional
Applicant
BIOANA SURGICAL INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/1981
Days to Decision
54 days