The following data is part of a premarket notification filed by Carefusion 2200 Inc. with the FDA for Snowden-pencer Ergonomic Take-apart In-line And Pistol Grip Laparoscopic Instruments.
| Device ID | K151036 |
| 510k Number | K151036 |
| Device Name: | Snowden-Pencer Ergonomic Take-Apart In-Line And Pistol Grip Laparoscopic Instruments |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CAREFUSION 2200 INC. 72 N. FAIRWAY DRIVE Vernon Hills, IL 60061 |
| Contact | Jane Weber |
| Correspondent | Jane Weber CAREFUSION 2200 INC. 72 N. FAIRWAY DRIVE Vernon Hills, IL 60061 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2016-02-01 |
| Summary: | summary |