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510(k) K082460

CENEFOM PVA SURGICAL SPEAR by Longtek Scientific Co., Ltd. — Product Code HOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2008
Date Received
August 26, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

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