The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213.
| Device ID | K082156 |
| 510k Number | K082156 |
| Device Name: | ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TELEFLEX MEDICAL 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Angela Bouse |
| Correspondent | Angela Bouse TELEFLEX MEDICAL 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-30 |
| Decision Date | 2008-09-10 |
| Summary: | summary |