The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Microfrance Laparoscopic Manual Surgical Instruments.
| Device ID | K080257 |
| 510k Number | K080257 |
| Device Name: | MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Jayme Wilson |
| Correspondent | Jayme Wilson MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-31 |
| Decision Date | 2008-05-22 |
| Summary: | summary |