510(k) K913992
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1991
- Date Received
- September 5, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Aspiration And Injection, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type