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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 K953055
Device Name MISTASSIST BREATHING EXERCISER
Applicant
THE MERLIN CORP.
1127 GARRIDO DR.
CAMARILLO,  CA  93010
Applicant Contact PAUL DWORK
Correspondent
THE MERLIN CORP.
1127 GARRIDO DR.
CAMARILLO,  CA  93010
Correspondent Contact PAUL DWORK
Regulation Number868.5690
Classification Product Code
BWF  
Date Received06/30/1995
Decision Date 02/08/1996
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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