510(k) K770299
K770299 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "TYGON M-60/TYGON M-70". The FDA issued a decision of Substantially Equivalent on March 16, 1977. The device falls under product code FID (Tubing, Dialysate), a Class II device regulated under 21 CFR 876.5820. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1977
- Date Received
- February 14, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Dialysate
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type