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510(k) K915502

MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES by Medline — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1992
Date Received
December 9, 1991
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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