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510(k) K102971

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK by Microtek Medical, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2011
Date Received
October 6, 2010
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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