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'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001434
510(k) Type
Traditional
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Country
United States
FDA Decision
Substantially Equivalent for Some Indications
Decision Date
6/12/2000
Days to Decision
35 days

'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001434
510(k) Type
Traditional
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Country
United States
FDA Decision
Substantially Equivalent for Some Indications
Decision Date
6/12/2000
Days to Decision
35 days