The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As Tyco Healthcar with the FDA for Sils Port Model Silspt15.
| Device ID | K093372 |
| 510k Number | K093372 |
| Device Name: | SILS PORT MODEL SILSPT15 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Angela Van Arsdale |
| Correspondent | Angela Van Arsdale COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-29 |
| Decision Date | 2009-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884523002659 | K093372 | 000 |
| 20884523002635 | K093372 | 000 |
| 20884523002642 | K093372 | 000 |