510(k) K980133

BAUSCH & LOMB WETTING AND SOAKING SOLUTION by Polymer Technology Corp. — Product Code LPN

K980133 is an FDA 510(k) premarket notification submitted by Polymer Technology Corp. for the device "BAUSCH & LOMB WETTING AND SOAKING SOLUTION". The FDA issued a decision of Substantially Equivalent on March 11, 1998. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Polymer Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 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