510(k) K021977

HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR by Contamac, Ltd. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2002
Date Received
June 17, 2002
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