The following data is part of a premarket notification filed by Surgical Innovations Plc with the FDA for Portland Trocars.
| Device ID | K962193 |
| 510k Number | K962193 |
| Device Name: | PORTLAND TROCARS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SURGICAL INNOVATIONS PLC 1070 THORNWOOD LN. Dacula, GA 30211 -3007 |
| Contact | Michael A Clark |
| Correspondent | Michael A Clark SURGICAL INNOVATIONS PLC 1070 THORNWOOD LN. Dacula, GA 30211 -3007 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-07 |
| Decision Date | 1996-08-28 |
| Summary: | summary |