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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K002831
Device Name VEGA ULTRASONIC NEBULIZER
Applicant
Vega Technologies, Inc.
11f-13, 100 Chang-Chun Rd.
Taipei,  TW 104
Applicant Contact JOSEPH LU
Correspondent
Vega Technologies, Inc.
11f-13, 100 Chang-Chun Rd.
Taipei,  TW 104
Correspondent Contact JOSEPH LU
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/11/2000
Decision Date 05/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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