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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 K082899
Device Name DYNAMIPEAK PEAK FLOW METER
Applicant
Dynamitech Medical, Inc.
Pacific Northwest Branck
611 S. Schoolhouse Creek Rd.
Grants Pass,  OR  97526
Applicant Contact KEITH LOWREY
Correspondent
Dynamitech Medical, Inc.
Pacific Northwest Branck
611 S. Schoolhouse Creek Rd.
Grants Pass,  OR  97526
Correspondent Contact KEITH LOWREY
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/30/2008
Decision Date 03/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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