510(k) K864294
K864294 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "HENKE-JECT PRESSURE SYRINGE (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on November 4, 1987. The device falls under product code EGM (Injector, Jet, Mechanical-Powered), a Class II device regulated under 21 CFR 872.4475. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1987
- Date Received
- October 31, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Jet, Mechanical-Powered
- Device Class
- Class II
- Regulation Number
- 872.4475
- Review Panel
- DE
- Submission Type