510(k) K001731
K001731 is an FDA 510(k) premarket notification submitted by Avid Medical, Inc. for the device "AVID-NIT LOSS OF RESISTANCE SYRINGE". The FDA issued a decision of Substantially Equivalent on August 29, 2000. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Avid Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2000
- Date Received
- June 7, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type