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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 K954492
Device Name MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
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 Number868.5690
Classification Product Code
BWF  
Date Received09/27/1995
Decision Date 10/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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