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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 K980951
Device Name ONEFLOW
Applicant
Sti Medical
908 Pompton Ave.
Cedar Grove,  NJ  07009
Applicant Contact LAUREN R ZIEGLER
Correspondent
Sti Medical
908 Pompton Ave.
Cedar Grove,  NJ  07009
Correspondent Contact LAUREN R ZIEGLER
Regulation Number868.1860
Classification Product Code
BZH  
Date Received03/13/1998
Decision Date 02/25/2000
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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