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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K871351
Device Name H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
Applicant
Holter-Hausner Intl.
Third And Mill St.S
P.O. Box 100
Bridgeport,  PA  19405
Applicant Contact JOHN R BOLLES
Correspondent
Holter-Hausner Intl.
Third And Mill St.S
P.O. Box 100
Bridgeport,  PA  19405
Correspondent Contact JOHN R BOLLES
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/06/1987
Decision Date 05/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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