The following data is part of a premarket notification filed by Carefusion 2200, Inc. with the FDA for Snowden Pencer Laparoscopic Ergonomic Reposable Scissors.
| Device ID | K113407 |
| 510k Number | K113407 |
| Device Name: | SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CAREFUSION 2200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Kate Fuller |
| Correspondent | Kate Fuller CAREFUSION 2200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-18 |
| Decision Date | 2012-09-07 |
| Summary: | summary |