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510(k) K062899

MICROTEK MEDICAL SURGICAL GOWN/TOGA by Microtek Medical, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2007
Date Received
September 27, 2006
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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