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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tracheostomy And Nasal Suctioning Kit
510(k) Number K862663
Device Name TRACHEOSTOMY CARE TRAY
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
Classification Product Code
LRQ  
Date Received07/14/1986
Decision Date 07/30/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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