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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, oxygen, low concentration, venturi
510(k) Number K860874
Device Name VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC
Applicant
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
DIVISION OF DIEMOLDING CORP.
CANASTOTA,  NY  13032
Applicant Contact RONALD N MCHENRY
Correspondent
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
DIVISION OF DIEMOLDING CORP.
CANASTOTA,  NY  13032
Correspondent Contact RONALD N MCHENRY
Regulation Number868.5600
Classification Product Code
BYF  
Date Received02/25/1986
Decision Date 03/19/1986
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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