510(k) K923285
K923285 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE". The FDA issued a decision of Substantially Equivalent on September 15, 1992. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), a Class I device regulated under 21 CFR 872.4565. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 1992
- Date Received
- July 6, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Syringe, Air And/Or Water
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type