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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K031860
Device Name SK MED ME202 MONITORING MIXER
Applicant
Sk Med
16000 Sherman Way #224
Van Nuys,  CA  91406
Applicant Contact DIPAK GHOSH
Correspondent
Sk Med
16000 Sherman Way #224
Van Nuys,  CA  91406
Correspondent Contact DIPAK GHOSH
Regulation Number868.5330
Classification Product Code
BZR  
Subsequent Product Code
CCL  
Date Received06/16/2003
Decision Date 01/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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