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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 K912866
Device Name PEAK EXPIRATORY FLOW METER
Applicant
Health Products, Inc.
908 Pompton Ave.
Unit B2
Cedar Grove,  NJ  07009
Applicant Contact LAUREN R ZIEGLER
Correspondent
Health Products, Inc.
908 Pompton Ave.
Unit B2
Cedar Grove,  NJ  07009
Correspondent Contact LAUREN R ZIEGLER
Regulation Number868.1860
Classification Product Code
BZH  
Date Received06/28/1991
Decision Date 08/13/1992
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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