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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, airway pressure (inspiratory force)
510(k) Number K032593
Device Name MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
Applicant
MERCURY MEDICAL
11300 49TH ST. NORTH
CLEARWATER,  FL  33762 -4800
Applicant Contact WAYNE GLOVER
Correspondent
MERCURY MEDICAL
11300 49TH ST. NORTH
CLEARWATER,  FL  33762 -4800
Correspondent Contact WAYNE GLOVER
Regulation Number868.1780
Classification Product Code
BXR  
Date Received08/22/2003
Decision Date 02/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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