The following data is part of a premarket notification filed by Tyco Intl. (us), Inc. with the FDA for Auto Suture* Soft Thoracoport** Obturator And Sleeve.
| Device ID | K992288 |
| 510k Number | K992288 |
| Device Name: | AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TYCO INTL. (US), INC. 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Christopher A Graham |
| Correspondent | Christopher A Graham TYCO INTL. (US), INC. 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-07 |
| Decision Date | 1999-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521081239 | K992288 | 000 |
| 10884521081222 | K992288 | 000 |
| 10884521081215 | K992288 | 000 |
| 10884521081208 | K992288 | 000 |
| 10884521081192 | K992288 | 000 |
| 10884521081185 | K992288 | 000 |
| 10884521081178 | K992288 | 000 |