510(k) K913992
K913992 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "ASPIRATION/INJECTION NEEDLE". The FDA issued a decision of Substantially Equivalent on October 30, 1991. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.
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