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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Airway Pressure (Inspiratory Force)
510(k) Number K873498
Device Name INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING
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 Number868.1780
Classification Product Code
BXR  
Date Received08/31/1987
Decision Date 03/09/1988
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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