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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 K983002
Device Name MYSTIQUE ULTRASONIC NEBULIZER
Applicant
AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO,  NY  14228
Applicant Contact EDWARD VRANA
Correspondent
AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO,  NY  14228
Correspondent Contact EDWARD VRANA
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/28/1998
Decision Date 10/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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