510(k) K001960

RIGID GAS PERMEABLE CONTACT LENS by Polymer Technology — Product Code HQD

K001960 is an FDA 510(k) premarket notification submitted by Polymer Technology for the device "RIGID GAS PERMEABLE CONTACT LENS". The FDA issued a decision of Substantially Equivalent on August 28, 2000. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Polymer Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2000
Date Received
June 27, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Other Material) - Daily
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type