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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 K896953
Device Name MODIFIED ASSESS(R) PEAK FLOW METER
Applicant
Health Products, Inc.
908 Pompton Ave.
Unit B2
Cedar Grove,  NJ  07009
Applicant Contact FRANK J ALVINO
Correspondent
Health Products, Inc.
908 Pompton Ave.
Unit B2
Cedar Grove,  NJ  07009
Correspondent Contact FRANK J ALVINO
Regulation Number868.1860
Classification Product Code
BZH  
Date Received12/05/1989
Decision Date 01/30/1990
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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