510(k) K924517
K924517 is an FDA 510(k) premarket notification submitted by Nusurg, Inc. for the device "AVITENE DISPENSER SYRINGE". The FDA issued a decision of Substantially Equivalent on Oct 27, 1993. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Nusurg, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 27, 1993
- Date Received
- Sep 4, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Syringe, Irrigating (Non Dental)
- Device Class
- Class I
- Regulation Number
- 880.6960
- Review Panel
- HO
- Submission Type
- 510(k) Exempt