510(k) K980147

YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION by Automatic Liquid Packaging, Inc. — Product Code LPN

K980147 is an FDA 510(k) premarket notification submitted by Automatic Liquid Packaging, Inc. for the device "YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION". The FDA issued a decision of Substantially Equivalent on April 13, 1998. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Automatic Liquid Packaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1998
Date Received
January 15, 1998
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