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510(k) K052462

G-COAT by GC America, Inc. — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2005
Date Received
September 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type

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