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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, therapeutic (incentive)
510(k) Number K942919
Device Name MERCURY EXPIRATORY RESISTANCE EXERCISER
Applicant
MERCURY ENT., INC. D/B/A MERCURY MEDICAL
11300 A-49TH.STREET NORTH
CLEARWATER,  FL  34622 -4800
Applicant Contact KATHY L HANN
Correspondent
MERCURY ENT., INC. D/B/A MERCURY MEDICAL
11300 A-49TH.STREET NORTH
CLEARWATER,  FL  34622 -4800
Correspondent Contact KATHY L HANN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received06/21/1994
Decision Date 09/19/1994
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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