510(k) K992028

REFRESH CONTACTS LUBRICATING AND REWETTING DROPS by Allergan, Inc. — Product Code LPN

K992028 is an FDA 510(k) premarket notification submitted by Allergan, Inc. for the device "REFRESH CONTACTS LUBRICATING AND REWETTING DROPS". The FDA issued a decision of Substantially Equivalent on October 7, 1999. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Allergan, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1999
Date Received
June 16, 1999
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type