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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 K991561
Device Name ROADRUNNER, PEP THERAPY DEVICE
Applicant
DHD HEALTHCARE CORP.
ONE MADISON ST.
WAMPSVILLE,  NY  13163
Applicant Contact LARRY WEINSTEIN
Correspondent
DHD HEALTHCARE CORP.
ONE MADISON ST.
WAMPSVILLE,  NY  13163
Correspondent Contact LARRY WEINSTEIN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received05/04/1999
Decision Date 11/10/1999
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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