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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Valve, Non-Rebreathing
510(k) Number K883988
Device Name NON-REBREATHING TEE PIECE (NRTP)
Applicant
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
DIVISION OF DIEMOLDING CORP.
CANASTOTA,  NY  13032
Applicant Contact JEAN WALLACE
Correspondent
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
DIVISION OF DIEMOLDING CORP.
CANASTOTA,  NY  13032
Correspondent Contact JEAN WALLACE
Regulation Number868.5870
Classification Product Code
CBP  
Date Received09/20/1988
Decision Date 10/07/1988
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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