510(k) K864139
K864139 is an FDA 510(k) premarket notification submitted by Ranfac, Corp. for the device "RANFAC CUT BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on November 5, 1986. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Ranfac, Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1986
- Date Received
- October 22, 1986
- 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