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AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043219
510(k) Type
Traditional
Applicant
INTERACOUSTICS AS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/2005
Days to Decision
74 days
Submission Type
Statement

AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043219
510(k) Type
Traditional
Applicant
INTERACOUSTICS AS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/2005
Days to Decision
74 days
Submission Type
Statement