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510(k) K040912

HYDROGEL CANALICULAR PLUG by Partners IN Biomaterials, Inc. — Product Code LZU

K040912 is an FDA 510(k) premarket notification submitted by Partners IN Biomaterials, Inc. for the device "HYDROGEL CANALICULAR PLUG". The FDA issued a decision of Substantially Equivalent on November 16, 2004. The device falls under product code LZU (Plug, Punctum), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2004
Date Received
April 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plug, Punctum
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

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FDA data resources