510(k) K970890
K970890 is an FDA 510(k) premarket notification submitted by Tri-Med Specialties, Inc. for the device "#ES-32 SUCTION CATHETER 32 FR.". The FDA issued a decision of Substantially Equivalent on May 23, 1997. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Tri-Med Specialties, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1997
- Date Received
- March 11, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type