The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As United States with the FDA for Sils Port, Models Silspt5, Silspt12.
| Device ID | K082619 |
| 510k Number | K082619 |
| Device Name: | SILS PORT, MODELS SILSPT5, SILSPT12 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Robert Zott |
| Correspondent | Robert Zott COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2008-11-07 |
| Summary: | summary |