510(k) K932001
K932001 is an FDA 510(k) premarket notification submitted by Allison Medical, Inc. for the device "ALLISON MEDICAL SYRINGE". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Allison Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1994
- Date Received
- April 9, 1993
- 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