510(k) K000932
K000932 is an FDA 510(k) premarket notification submitted by Advanced Medical Products, Inc. for the device "ARACHNOPHLEBECTOMY NEEDLE". The FDA issued a decision of Substantially Equivalent on May 17, 2000. The device falls under product code GAH (Stylet, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Advanced Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2000
- Date Received
- March 23, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stylet, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type