510(k) K821703
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