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510(k) K010401

TRI-PLEX ADAPTER by The Medical Device Group, Inc. — Product Code MOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2002
Date Received
February 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory To Continuous Ventilator (Respirator)
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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