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PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K962714
510(k) Type
Traditional
Applicant
PASSY-MUIR, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/28/1996
Days to Decision
108 days
Submission Type
Statement

PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K962714
510(k) Type
Traditional
Applicant
PASSY-MUIR, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/28/1996
Days to Decision
108 days
Submission Type
Statement