510(k) K833460
K833460 is an FDA 510(k) premarket notification submitted by Aldrich Chemical Co., Inc. for the device "SYRINGE,PISTON NEEDLE, HOLLOW LUMEN". The FDA issued a decision of Substantially Equivalent on Nov 28, 1983. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Aldrich Chemical Co., Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 28, 1983
- Date Received
- Oct 5, 1983
- 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
- 510(k)