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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name compressor, air, portable
510(k) Number K072634
Device Name EMG TRITON -COMP,MODEL NCA01-XXX SERIES
Applicant
EMG TECHNOLOGY CO., LTD.
4F-2, NO. 210, 38 RD.
TAICHUNG INDUSTRIAL PARK
SHITUEN CHIU, TAICHUNG,  TW 40768
Applicant Contact SALLY CHUANG
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number868.6250
Classification Product Code
BTI  
Date Received09/18/2007
Decision Date 11/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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