510(k) K870164

SUMMIT OPTICS SOFT CONTACT LENS CASE by Dayton Mfg. Co. — Product Code LRX

K870164 is an FDA 510(k) premarket notification submitted by Dayton Mfg. Co. for the device "SUMMIT OPTICS SOFT CONTACT LENS CASE". The FDA issued a decision of Substantially Equivalent on February 10, 1987. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Dayton Mfg. Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1987
Date Received
January 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type