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 Implantable Drug Delivery System**.
| Device ID | K952748 |
| 510k Number | K952748 |
| Device Name: | AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 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 | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-16 |
| Decision Date | 1995-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521099272 | K952748 | 000 |
| 20884521099026 | K952748 | 000 |
| 20884521099002 | K952748 | 000 |
| 20884521098999 | K952748 | 000 |
| 10884521099401 | K952748 | 000 |
| 10884521099395 | K952748 | 000 |
| 10884521099388 | K952748 | 000 |
| 10884521099340 | K952748 | 000 |
| 10884521099333 | K952748 | 000 |
| 10884521099319 | K952748 | 000 |
| 10884521099258 | K952748 | 000 |
| 10884521099241 | K952748 | 000 |
| 10884521099234 | K952748 | 000 |
| 20884521099033 | K952748 | 000 |
| 20884521099040 | K952748 | 000 |
| 20884521099057 | K952748 | 000 |
| 20884521099019 | K952748 | 000 |
| 10884521176065 | K952748 | 000 |
| 20884521099194 | K952748 | 000 |
| 20884521099187 | K952748 | 000 |
| 20884521099170 | K952748 | 000 |
| 20884521099163 | K952748 | 000 |
| 20884521099156 | K952748 | 000 |
| 20884521099149 | K952748 | 000 |
| 20884521099132 | K952748 | 000 |
| 20884521099101 | K952748 | 000 |
| 20884521099071 | K952748 | 000 |
| 20884521099064 | K952748 | 000 |
| 10884521099203 | K952748 | 000 |