510(k) K832398
K832398 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "DYNACOR CONNECTING TUBING". The FDA issued a decision of Substantially Equivalent on Aug 24, 1983. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 24, 1983
- Date Received
- Jul 20, 1983
- 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