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* Anti-fog Device**.
| Device ID | K944249 |
| 510k Number | K944249 |
| Device Name: | AUTO SUTURE* ANTI-FOG DEVICE** |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Jonathan Gilbert |
| Correspondent | Jonathan Gilbert UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-30 |
| Decision Date | 1994-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521066394 | K944249 | 000 |