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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K881428
Device Name OXY-CATH
Applicant
Pulmonary Medical Devices, Inc.
40 Industrial Rd.
Berkley Heights,  NJ  07922
Applicant Contact DAVID MILLER
Correspondent
Pulmonary Medical Devices, Inc.
40 Industrial Rd.
Berkley Heights,  NJ  07922
Correspondent Contact DAVID MILLER
Regulation Number868.6810
Classification Product Code
BSY  
Date Received04/05/1988
Decision Date 06/10/1988
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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