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DILATOR/SHEATH SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K842632
510(k) Type
Traditional
Applicant
AMERICAN EDWARDS LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/2/1984
Days to Decision
88 days

DILATOR/SHEATH SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K842632
510(k) Type
Traditional
Applicant
AMERICAN EDWARDS LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/2/1984
Days to Decision
88 days