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510(k) K043004

STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 by Viasys Medsystems — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2005
Date Received
November 1, 2004
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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