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510(k) K982058

ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN by Encompass Group, LLC — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1999
Date Received
June 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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