510(k) K813228
K813228 is an FDA 510(k) premarket notification submitted by Northern Medical Industries for the device "CONNECTING TUBE". The FDA issued a decision of Substantially Equivalent on Nov 27, 1981. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Northern Medical Industries has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 27, 1981
- Date Received
- Nov 10, 1981
- 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