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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
510(k) Number K860869
Device Name MEDIUM CONCENTRATION OXYGEN MASKS
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 Number868.5580
Classification Product Code
BYG  
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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