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510(k) K071203

SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES by Optikem International, Inc. — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2007
Date Received
May 1, 2007
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

Other clearances by Optikem International, Inc.

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