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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 K863497
Device Name SUCTION CATHETER KIT
Applicant
Welmed Systems, Inc.
P.O. Box 599
West Swanzey,  NH  03469
Applicant Contact DAVID B PETERS
Correspondent
Welmed Systems, Inc.
P.O. Box 599
West Swanzey,  NH  03469
Correspondent Contact DAVID B PETERS
Regulation Number868.6810
Classification Product Code
BSY  
Date Received09/09/1986
Decision Date 10/06/1986
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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