The following data is part of a premarket notification filed by Carefusion 2200 Inc with the FDA for Snowden-pencer Microlap 3mm Laparoscopic Instruments.
| Device ID | K163615 |
| 510k Number | K163615 |
| Device Name: | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CareFusion 2200 Inc 75 North Fairway Drive Vernon Hills, IL 60061 |
| Contact | Jane Weber |
| Correspondent | Jane Weber CareFusion 2200 Inc 75 North Fairway Drive Vernon Hills, IL 60061 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-05-04 |
| Summary: | summary |