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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 K954277
Device Name ASTECH PEAK FLOW METER
Applicant
CENTER LABORATORIES, INC.
35 CHANNEL DR.
PORT WASHINGTON,  NY  11050
Applicant Contact RICHARD J MANASSA
Correspondent
CENTER LABORATORIES, INC.
35 CHANNEL DR.
PORT WASHINGTON,  NY  11050
Correspondent Contact RICHARD J MANASSA
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/11/1995
Decision Date 02/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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