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510(k) K020510

SMOKE EVACUATION HOSES/TUBING by Dm Medical, Inc. — Product Code FYD

K020510 is an FDA 510(k) premarket notification submitted by Dm Medical, Inc. for the device "SMOKE EVACUATION HOSES/TUBING". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2002
Date Received
February 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

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FDA data resources