The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Disposable Pneumoperitoneum Needle.
| Device ID | K863330 |
| 510k Number | K863330 |
| Device Name: | DISPOSABLE PNEUMOPERITONEUM NEEDLE |
| Classification | Pneumoperitoneum Needle |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Walter S Hennig |
| Correspondent | Walter S Hennig UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1986-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521080812 | K863330 | 000 |
| 20884521080802 | K863330 | 000 |