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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K042294
Device Name SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)
Applicant
Suiter Enterprises, Inc.
21230 SE 363rd St.
Auburn,  WA  98092
Applicant Contact TIMOTHY J.S. SUITER
Correspondent
Suiter Enterprises, Inc.
21230 SE 363rd St.
Auburn,  WA  98092
Correspondent Contact TIMOTHY J.S. SUITER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/24/2004
Decision Date 09/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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