The following data is part of a premarket notification filed by Sharp Medical Prducts, Llc with the FDA for Reactor(tm) Trocar And Sleeve.
| Device ID | K150549 |
| 510k Number | K150549 |
| Device Name: | Reactor(TM) Trocar And Sleeve |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Sharp Medical Prducts, LLC 7694 E. Rose Garden Lane Scottsdale, AZ 85255 |
| Contact | Chris Salvino |
| Correspondent | Melanie Cox McFarlane Medical, Inc. 2571 Kaneville Ct Geneva, IL 60134 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-03 |
| Decision Date | 2015-06-01 |
| Summary: | summary |