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510(k) K062332

ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION by Altaire Pharmaceuticals, Inc. — Product Code LPN

K062332 is an FDA 510(k) premarket notification submitted by Altaire Pharmaceuticals, Inc. for the device "ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION". The FDA issued a decision of Substantially Equivalent on April 25, 2007. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2007
Date Received
August 10, 2006
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

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FDA data resources