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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name connector, airway (extension)
510(k) Number K911294
Device Name ULTRASET CATHETER
Applicant
DHD DIEMOLDING HEALTHCARE DIV.
125 RASBACH ST.
CANASTOTA,  NY  13032
Applicant Contact JEAN WALLACE
Correspondent
DHD DIEMOLDING HEALTHCARE DIV.
125 RASBACH ST.
CANASTOTA,  NY  13032
Correspondent Contact JEAN WALLACE
Regulation Number868.5810
Classification Product Code
BZA  
Date Received03/25/1991
Decision Date 06/10/1991
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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