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510(k) K072560

ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) by Teikoku Pharma USA, Inc. — Product Code NAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2008
Date Received
September 11, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

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