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DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K954175
510(k) Type
Traditional
Applicant
ORIGIN MEDSYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/9/1995
Days to Decision
65 days
Submission Type
Summary

DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K954175
510(k) Type
Traditional
Applicant
ORIGIN MEDSYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/9/1995
Days to Decision
65 days
Submission Type
Summary