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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K980725
Device Name EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
Applicant
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Applicant Contact LORI ZURAVLEFF
Correspondent
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Correspondent Contact LORI ZURAVLEFF
Regulation Number868.5870
Classification Product Code
CBP  
Date Received02/24/1998
Decision Date 08/24/1998
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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