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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K102971
Device Name FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
Applicant
Microtek Medical, Inc.
602 Lehmberg Rd.
Columbus,  MS  39702
Applicant Contact THOMAS B BONNER, JR.
Correspondent
Microtek Medical, Inc.
602 Lehmberg Rd.
Columbus,  MS  39702
Correspondent Contact THOMAS B BONNER, JR.
Regulation Number878.4040
Classification Product Code
FYA  
Date Received10/06/2010
Decision Date 02/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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