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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 K970507
Device Name PEAK FLOW METER
Applicant
Intl. Medical, Inc.
14470 Burnsville Pkwy.
Burnsville,  MN  55306
Applicant Contact WARREN V BIGELOW
Correspondent
Intl. Medical, Inc.
14470 Burnsville Pkwy.
Burnsville,  MN  55306
Correspondent Contact WARREN V BIGELOW
Regulation Number868.1860
Classification Product Code
BZH  
Date Received02/10/1997
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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