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FDA 510(k), K070628, OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
FDA 510(k), K070628, OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
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510(K) Number: K070628
Device Name: OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
Manufacturer: CONTAMAC LTD.
Device Classification Name: lens, contact (other material) - daily
Regulation Number: 886.5916
Classification Product Code: HQD
Date Received: 03/07/2007
Decision Date: 05/01/2007
Regulation Medical Specialty: Ophthalmic
Device Name: OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
Manufacturer: CONTAMAC LTD.
Device Classification Name: lens, contact (other material) - daily
Regulation Number: 886.5916
Classification Product Code: HQD
Date Received: 03/07/2007
Decision Date: 05/01/2007
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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