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TEMPORARY OCCLUSION BALLOON SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K972777
510(k) Type
Traditional
Applicant
PERCUSURGE, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/11/1998
Days to Decision
229 days
Submission Type
Statement

TEMPORARY OCCLUSION BALLOON SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K972777
510(k) Type
Traditional
Applicant
PERCUSURGE, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/11/1998
Days to Decision
229 days
Submission Type
Statement