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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K961779
Device Name MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
Applicant
Avion Medical Products, Inc.
4361 Harvester Rd., Unit 1
Burlington, Ontario,  CA L7L 5M4
Applicant Contact ROBERT L JAMES
Correspondent
Avion Medical Products, Inc.
4361 Harvester Rd., Unit 1
Burlington, Ontario,  CA L7L 5M4
Correspondent Contact ROBERT L JAMES
Regulation Number868.1860
Classification Product Code
BZH  
Date Received05/08/1996
Decision Date 06/13/1997
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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