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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name strap, head, gas mask
510(k) Number K854537
Device Name HEADSTRAP
Applicant
LIFE DESIGN SYSTEMS, INC.
11017 WEST LAYTON AVE.
MILWAUKEE,  WI  53228
Applicant Contact GILBERT M KIRK
Correspondent
LIFE DESIGN SYSTEMS, INC.
11017 WEST LAYTON AVE.
MILWAUKEE,  WI  53228
Correspondent Contact GILBERT M KIRK
Regulation Number868.5560
Classification Product Code
BTK  
Date Received11/13/1985
Decision Date 12/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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