510(k) K914980
K914980 is an FDA 510(k) premarket notification submitted by Medical Fittings, Inc. for the device "HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 21, 1992. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Medical Fittings, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1992
- Date Received
- November 6, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Pressure And Accessories
- Device Class
- Class I
- Regulation Number
- 868.5860
- Review Panel
- AN
- Submission Type