510(k) K002319

PURILENS SALINE SOLUTION by Purilens, Inc. — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2000
Date Received
July 31, 2000
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