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510(k) K050851

DELTA PUNCTUM PLUG by Delta Life Science, Inc. — Product Code LZU

K050851 is an FDA 510(k) premarket notification submitted by Delta Life Science, Inc. for the device "DELTA PUNCTUM PLUG". The FDA issued a decision of Substantially Equivalent on August 19, 2005. The device falls under product code LZU (Plug, Punctum), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2005
Date Received
April 4, 2005
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