510(k) K014162

MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND by Lobob Laboratories, Inc. — Product Code MRC

K014162 is an FDA 510(k) premarket notification submitted by Lobob Laboratories, Inc. for the device "MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND". The FDA issued a decision of Substantially Equivalent on January 15, 2002. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Lobob Laboratories, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2002
Date Received
December 19, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
Review Panel
OP
Submission Type