The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Chemosite Tunneler.
| Device ID | K961856 |
| 510k Number | K961856 |
| Device Name: | AUTO SUTURE CHEMOSITE TUNNELER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-14 |
| Decision Date | 1996-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521099265 | K961856 | 000 |
| 10884521099289 | K961856 | 000 |
| 10884521099371 | K961856 | 000 |
| 10884521099364 | K961856 | 000 |
| 10884521099357 | K961856 | 000 |
| 10884521099326 | K961856 | 000 |
| 10884521099302 | K961856 | 000 |
| 10884521099296 | K961856 | 000 |
| 20884521099224 | K961856 | 000 |