510(k) K880377
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1988
- Date Received
- January 27, 1988
- 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