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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K963347
Device Name REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
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 Number868.5965
Classification Product Code
BYE  
Date Received08/26/1996
Decision Date 03/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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