510(k) K873124
K873124 is an FDA 510(k) premarket notification submitted by Anchor Products Co. for the device "ANCHOR BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on September 8, 1987. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Anchor Products Co. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1987
- Date Received
- August 10, 1987
- 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