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RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964585
510(k) Type
Traditional
Applicant
TRIMEDYNE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/17/1997
Days to Decision
153 days
Submission Type
Summary

RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964585
510(k) Type
Traditional
Applicant
TRIMEDYNE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/17/1997
Days to Decision
153 days
Submission Type
Summary