510(k) K110221

EYE-CEPT STERILE SALINE SOLUTION by Optics Laboratory, Inc. — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2011
Date Received
January 25, 2011
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