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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K010401
Device Name TRI-PLEX ADAPTER
Applicant
THE MEDICAL DEVICE GROUP, INC.
PO BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
THE MEDICAL DEVICE GROUP, INC.
PO BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number868.5895
Classification Product Code
MOD  
Date Received02/12/2001
Decision Date 10/30/2002
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
Recalls CDRH Recalls
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