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subpart-f—therapeutic-devices/

GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K030027
510(k) Type: Traditional
Applicant: GELFLEX LABORATORIES
Country: Australia
FDA Decision: Substantially Equivalent
Decision Date: 4/1/2003
Days to Decision: 88 days
Submission Type: Statement

FDA Browser

subpart-f—therapeutic-devices/

GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K030027
510(k) Type: Traditional
Applicant: GELFLEX LABORATORIES
Country: Australia
FDA Decision: Substantially Equivalent
Decision Date: 4/1/2003
Days to Decision: 88 days
Submission Type: Statement