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510(k) K003855

HYALOMATRIX CO by Fidia Advanced Biopolymers Srl — Product Code KHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2001
Date Received
December 13, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

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