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SOFSILK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964581
510(k) Type
Traditional
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
Country
United States
FDA Decision
Substantially Equivalent for Some Indications
Decision Date
1/16/1997
Days to Decision
62 days

SOFSILK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964581
510(k) Type
Traditional
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
Country
United States
FDA Decision
Substantially Equivalent for Some Indications
Decision Date
1/16/1997
Days to Decision
62 days