510(k) K984383

ULTRACARE NEUTRALIZING TABLETS by Allergan, Inc. — Product Code LPN

K984383 is an FDA 510(k) premarket notification submitted by Allergan, Inc. for the device "ULTRACARE NEUTRALIZING TABLETS". The FDA issued a decision of Substantially Equivalent on December 18, 1998. 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
December 18, 1998
Date Received
December 8, 1998
Clearance Type
Special
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