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NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001440
510(k) Type
Traditional
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/13/2000
Days to Decision
189 days
Submission Type
Summary

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001440
510(k) Type
Traditional
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/13/2000
Days to Decision
189 days
Submission Type
Summary