510(k) K093254

AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION by Abbott Medical Optics, Inc. — Product Code LPN

K093254 is an FDA 510(k) premarket notification submitted by Abbott Medical Optics, Inc. for the device "AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION". The FDA issued a decision of Substantially Equivalent on September 15, 2010. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Abbott Medical Optics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2010
Date Received
October 16, 2009
Clearance Type
Traditional
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