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510(k) K992436

GOWN BACK, MODEL 13-403N; 13-404N; 13-405N by Techstyles — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2000
Date Received
July 22, 1999
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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