510(k) K821703

MGN CONDUCTIVE CONNECTING TUBE, STERILE by Mgn Medical Manufacturing, Inc. — Product Code BYY

K821703 is an FDA 510(k) premarket notification submitted by Mgn Medical Manufacturing, Inc. for the device "MGN CONDUCTIVE CONNECTING TUBE, STERILE". The FDA issued a decision of Substantially Equivalent on June 22, 1982. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Mgn Medical Manufacturing, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1982
Date Received
June 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Aspirating, Flexible, Connecting
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type