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subpart-f—therapeutic-devices/

POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K980818
510(k) Type: Traditional
Applicant: STEPHEN A. DUNN, INC.
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 3/30/1998
Days to Decision: 27 days
Submission Type: Summary

FDA Browser

subpart-f—therapeutic-devices/

POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K980818
510(k) Type: Traditional
Applicant: STEPHEN A. DUNN, INC.
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 3/30/1998
Days to Decision: 27 days
Submission Type: Summary