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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, airway pressure (includes gauge and/or alarm)
510(k) Number K954486
Device Name MERCURY AIRWAY PRESSURE MANOMETER
Applicant
MERCURY MEDICAL
11300-A 49TH ST. NORTH
CLEARWATER,  FL  34622 -4800
Applicant Contact KATHY L HANN
Correspondent
MERCURY MEDICAL
11300-A 49TH ST. NORTH
CLEARWATER,  FL  34622 -4800
Correspondent Contact KATHY L HANN
Regulation Number868.2600
Classification Product Code
CAP  
Date Received09/27/1995
Decision Date 04/25/1996
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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