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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
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