The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Xps 3000 System With Reciprocating Adapter And Suction Cannulae.
| Device ID | K010666 |
| 510k Number | K010666 |
| Device Name: | XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE |
| Classification | System, Suction, Lipoplasty For Removal |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Martin D Sargent |
| Correspondent | Martin D Sargent MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | QPB |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-06 |
| Decision Date | 2001-05-07 |
| Summary: | summary |