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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 K040485
Device Name MAXAIR SURGICAL HELMET SYSTEM
Applicant
Bio-Medical Devices, Inc.
17171 Daimler Ave.
Irvine,  CA  92614
Applicant Contact NICK HERBERT
Correspondent
Bio-Medical Devices, Inc.
17171 Daimler Ave.
Irvine,  CA  92614
Correspondent Contact NICK HERBERT
Regulation Number878.4040
Classification Product Code
FYA  
Date Received02/25/2004
Decision Date 10/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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